PHARMACEUTICAL and BIOTECH

J. Edgar and Associates Inc. is an industry Leader in Scientific, Clinical and Operations Recruitment at all Levels. If you are currently in the Market for a new employment opportunity, we invite you to view the current opportunities below.

Check frequently for the latest hot jobs...Principle Software Engineer...New Product Development...Director Regulatory Affairs...Director Clinical Development and Operations...Intermediate and Principal Stat Programmer...Optical Devices Manufacturing Engineer...Senior R+D Product Development Engineer Manager...Sr. Scientist...Sr. Scientist...Assoc. or Sr. Director Statistical Programming...Biostatistician...Senior Director...Director Sr. Director...Sr. Director and VP Level...Process Development Unit Head...Manager of Statistics...Team Lead...


PRINCIPAL SOFTWARE ENGINEER - DEVELOPMENT INFRASTRUCTURE AND OPERATIONS - LEADING MEDICAL TECHNOLOGY FIRM - BAY AREA - EXCELLENT PACKAGE!

We are currently seeking an experienced Software build infrastructure developer and Engineer to create and optimize the Development and Operations of new software for some of the most cutting edge Medical Technology currently in development.

The goal in this role is to be the Technical lead enabling streamlined software development, by managing and owning the entire build pipeline, DevOps toolchain and associated test environments from source control to software delivery. We are looking for a experienced Software engineer with proven success in creating a software Development and Operations infrastructure. Ideally, we are looking for solid experience creating DevOps infrastructure using Docker and Chef. See the full Tech and Tools listed below.

Responsibilities: Work very closely and integrate with the Development team to embrace culture change. Work with peer technical leaders and their teams to enable engineers to seamlessly create CI/CD pipelines for their software components. Focus on continuously improving the DevOps tooling and software delivery processes. Own and maintain highly reliable environments and toolchains with clear communication and timeliness of any disruptions to internal stakeholders. Leverage industry-standard techniques and processes to help enable and provide better feedback to the development community. Monitor and continually improve the capacity of our production environments infrastructure. Investigate and fix performance and scalability bottlenecks.

Experience: Minimum of a Bachelor's Degree in Computer science, IT, Software Engineering, or related discipline. Minimum of 7 years’ experience in Software Engineering development roles. Minimum of 3 years' experience maintaining and managing software build infrastructure. (i.e. Azure DevOps, Jenkins, TravisCI, TFS, TeamForge, etc.) Minimum of 3 years' experience with container technology and subsequent technologies (Docker, Kubernetes, Docker Swarm, Amazon ECS, Azure Service Fabric, Harbour, Helm, Packer, Terraform) Strong experience creating, maintaining, and supporting automated build pipelines. Strong experience in version control and source control management (Subversion, TFVC, Git) Experience deploying, managing, and maintaining at least 2 of the following SCM tool chain such as Jenkins, Artifactory, SonarQube, Nexus, TFS. Strong understanding of programming skill sets, structure, and Versioning. Strong working knowledge of MSBuild. Experience in an object-oriented programming language (Java, C++, C#, etc..) Experience in scripting languages such as Bash and Python. Experience and knowledge of Microsoft system administration and networking. Knowledge of test-driven development, software configuration management, and automated testing.  Experience managing a VMware-based virtualization environment or similar.

Assets for this role: Experience with system management technologies such as Puppet, Ansible, Salt, or Chef. Experience in managing an automated build pipeline for a mixed set of software assets. Strong interpersonal skills (verbal and written). Experience using Wix and/or InstallShield.

Salary - Above Market - Bonus - 10-15% - Location - San Francisco Bay Area, CALIFORNIA -

Call Jason Edgar at 416 225-2628 for all the details. Please send your CV directly to me for consideration: careers@jedgarcareers.com 


 R+D NEW PRODUCT DEVELOPMENT & PROJECT/PROGRAM MANAGER- BAY AREA-CALIFORNIA

We are currently seeking an experienced and polished R+D New Product Improvement Development and Team Program Manager who will lead teams to prepare for Phase Gate with relevant data to achieve commercial launch for new product development programs. Mentor, define and delegate requirements with best practices in improving the product development process and deliverables for core and extended teams.

In this role, you will ensure alignment of product value proposition, program scope, and strategic business objectives. By leading the program planning process, you will ensure requirements are clear and driven by customer needs and experiences. Defining program resource/budget needs with cross functional teams and communicating program updates to executive management, will help identify program risks, ensure a timely delivery of program milestones and problem resolution, including root cause analysis and corrective action plan.

Lead key technical design and commercial excellence reviews, constructively challenging the team for continuous product improvement initiatives to achieve maximum project success. Leads product development utilizing a multitude of processes including Project Management, Agile and other in house systems. Leads, directs, coaches, and mentors Core Team members to maximize project success by providing significant feedback to functional leaders regarding the performance of Core Team members that is considered in annual performance evaluations.

Must ensure programs are compliant with company’s Global Quality Management Systems while identifying creative ways to provide speed to the market in this Global organization. Building high morale, creating clear and common objectives for the purpose of facilitating harmonious team dynamics will help foster development in cross-functional teams and reach new Global product development milestones.

Ability to lead complex programs delivering the right outcomes balancing on time delivery, budget, Quality and market and customer expectations is the key to the success of this role. You must be highly skilled in integrated program planning along with tactical project planning, risk management, project execution and superior communication to all levels of the organization.

Bring your time management, continuous quality learning, relentless advocacy for the customer with a focus on meeting customer requirements to the table and we have a new and exciting career for you!

Education: Bachelor’s degree in technical field. MBA or PMP or similar is considered an asset.

Qualifications: Minimum of 5-10 years’ experience successfully leading complex, multi-year new product development programs delivered through high performing, cross-functional, teams based in a matrix organization. Experience in Medical Devices or life sciences industries is advantageous, including management of whole systems development covering hardware, firmware, software and reagents is strongly preferred. Exceptional analytical, critical thinking, problem solving coupled with strong business, strategic and financial acumen is considered a must have in this career role.

Location: Bay Area, California. A combination of office and home based to be successful in this role.

Salary: Above Market plus target bonus plan including a thorough and comprehensive benefits package.

Call Jason Edgar at 416 225-2628 for all the details. Please send your CV directly to me for consideration: careers@jedgarcareers.com 


DIRECTOR, US ONCOLOGY REGULATORY AFFAIRS-NJ, MA OR REMOTE

We are currently seeking an experienced filing lead to act as the Regulatory Affairs  Director for US Oncology.

In this Director of North America Regulatory Strategy (NA GRA) role, the incumbent will be primarily responsible for the development of innovative and robust US Regulatory strategies for pipeline and lifecycle assets in a growing Oncology portfolio. You will be accountable for the efficient and effective execution of US regulatory strategies while adhering to US regulatory and corporate guidelines. The US RA Lead will serve as Liaison to the US FDA for assigned Oncology projects in clinical development.

The ideal candidate will lead the strategic development of documentation submitted to the US FDA and lead FDA meetings and negotiations. In this high-profile role, you will represent the US Global RA perspective as a member of the project specific cross functional global regulatory team. You will be accountable to develop and maintain the US regulatory strategy documents and advise on US regulatory issues at internal meetings. As well, this role prospectively works with the labeling strategist and the global team to develop US prescribing information.

This role will also work with and participate on multi-disciplinary matrixed project teams to successfully meet project deliverables while adhering to regulatory requirements for programs and products. This role participates in the development and monitoring of the US regulatory environment and updating of standards and processes related to drug and biologics US regulations. Bring your coaching and mentoring personality to train junior staff supporting the RA teams. The position may be based in Northern NJ, NYC or Boston  MA or remote, home based.

Lead the strategic development of briefing materials and prepare teams for US FDA meetings. Participate in the development of and assess the appropriateness of submission documentation to support successful US INDs/BLAs/NDAs. Represent company at US FDA for assigned projects.

Requirements: At least 10-15 years’ regulatory experience in pharmaceutical drug development. Solid working knowledge of drug development process and US regulatory requirements. Demonstrated experience developing and implementing regulatory strategies for US INDs, BLA, and/or NDAs. Experience with rare disease drug development is an asset. Demonstrated experience successfully operating in a global environment. Advanced scientific degree preferred. B.A./B.S. or higher degree (s) in the sciences, or health related field minimum, with 10 years regulatory experience. Solid knowledge and understanding of complex medical and scientific subject matter as well as evolving US regulatory policy and guidance. Direct interaction/negotiation experience with US FDA.

Salary: Higher than average, full and thorough compensation package!

Location: New Jersey, MA, USA or Remote (home based).

Call Cris Murray 416 225-6386, VP Recruitment, J. Edgar and Associates Inc., to apply for this exciting career opportunity.

Please send your CV to me directly for consideration: jedgar@sympatico.ca in either a word or PDF format. Once you submit your CV, I will personally call you back to discuss and disclose our clients details so that you can determine your interest level.


ASSOCIATE AND SENIOR DIRECTOR CLINICAL DEVELOPMENT AND CLINICAL OPERATIONS, CANADA OR USA, REMOTE CRO $$

We are currently seeking two (2) committed, skilled, and customer-focused professionals to join an award winning team as Clinical Operations Leaders to develop and lead the Clinical Operations teams in a highly successful, full service, Clinical Research Organization specializing in every Therapeutic category from Phase I-IV. Bring your superior communication skills, quality deliverables, stellar customer service, and flexibility in meeting clients needs, and we have a dynamic career opportunity awaiting your exploration!

The Clinical Operations Leads serve as the clinical functional leads, accountable for the site management/clinical monitoring delivery of assigned tasks and projects as per scope. Will provide clear oversight and coordination of working across regions to ensure clinical project and site deliverables are met. Bring your leadership, mentoring, and technical support to the Clinical Operations team to ensure quality deliverables and achievement of milestones and financial goals. These high-profile roles will be responsible for tracking study progress and assessing compliance of the conduct of clinical trials with regulatory requirements, the clinical study protocol, study-specific plans, and Standard Operating Procedures.

In these customer facing roles, you will interact with Study Sponsors, Investigational sites, vendors and other functional departments related to site management and clinical monitoring activities to ensure timely and high-quality deliverables at all times. Ensure quality visibility of its progress through CTMS/eTMF and/or tracking tools. Review study scope of work, budget and protocol content and ensure the Clinical Operations team are aware of the parameters. Ensure alignment of clinical activities to budget, including identification of out-of-scope activities. Escalate to Project Managers any clinical/site management deliverables (timeline, quality, and budget) at risk, and any activities or requests which are out of contracted scope.

Develop, train, mentor, and guide clinical operations team on protocol specific plans, guidelines and timelines, with support from Clinical Operations Oversight, Project Management, Medical Monitoring, and Sponsors, to foster a team culture that supports the Clinical Operations team and results in staff retention. Coach and Mentor Clinical Operations Leads regarding functional clinical delivery, evaluation of project risks, and action-oriented implementation. Set priorities for the teams to complete and manage on a regional and site level. Participate in scheduled Study Management Team meetings for assigned projects, provide status updates and are accountable for deliverables. Organize and Lead CRA team meetings to provide study updates and perform training as needed. Author the Monitoring Plan and accountable for the Clinical Operations teams (scheduling and report submission/finalization) to ensure compliance with the Monitoring Plan and understand the monitoring strategy by providing technical expertise. Liaise across various clinical stakeholders to compile reports to track progress and performance metrics.

Act as point of contact for clinical site monitoring and Investigator site questions/issue escalation. Perform site management, review report progress status of the investigational sites. Communicate directly with sites to provide direction, assess performance, and propose alternatives to enhance performance of patient enrollment and data submission. Issue periodic clinical trial Newsletters when required.

 May conduct co-monitoring/preceptor oversight visits with CRA’s to evaluate staff’s ability and performance level. May perform Pre-Study, Site Initiation, Interim Monitoring/Remote, and or Closeout Visits as required.

Lead site feasibility and selection process. Support review of the documentation (review informed consent forms) to ensure clinical site comply with ICH-GCP and relevant regulations. Assist with negotiation of sites, contracts/budgets and prepare payments for Vendors/investigational sites. Assist with Preparation and submission of regulatory documents to regulatory agencies, authorities, IRBs and Research Ethics Committees. Collaborate with functional teams including Medical Monitoring, Pharmacovigilance, and Quality Assurance to ensure site compliance. Prepare, maintain and complete training on study specific sponsor SOP’s. May participate in Business Development activities including strategy, budget input and proposal development.

Equipment/Software: Microsoft Software (Word, Excel, PowerPoint, Project, Outlook, Calendar, Contacts, and Tasks). Knowledge of database systems, including Oracle InForm, MediData Rave, DFdiscover and other Electronic Capture systems. Flex Database Trial Master File and Clinical Trial Management System.

Qualifications include: Minimum BSc in life sciences or related field, MSc and/or MBA preferred. At least 6 years of Clinical Research Trial and/or monitoring experience. Thorough knowledge of ICH-GCP guidelines + regulations, and comprehension of medical terminology. Must have experience leading and managing groups within a CRO, Biopharmaceutical setting.

Energized, polished and ready for your next challenge, please call today!

Salary: above market, highly competitive. Bonus 10-15%, full and thorough benefits package, long term incentive plan!

Location: Canada and/or USA, remote.

Call Cris Murray 416 225-6386, VP Recruitment, J. Edgar and Associates Inc., to apply for this exciting career opportunity.

Please send your CV to me directly for consideration: jedgar@sympatico.ca in either a word or PDF format. Once you submit your CV, I will personally call you back to discuss and disclose our clients details so that you can determine your interest level.


 INTERMEDIATE, SENIOR AND PRINCIPAL STATISTICAL PROGRAMMERS-WFH-USA OR CANADA TO $200K BASE PLUS 401K, BONUS, BENEFITS AND PENSION

Our client continues to grow and we are seeking several talented Statistical Programmers to perform senior level Statistical Programming tasks at a leadership level to drive continued success in this exciting field of clinical research. Key Accountabilities: Lead study teams by participating in resource planning and managing timelines and deliverables. This includes managing programming assignments for project team members and following up on task status to ensure deliverables are completed on time and with quality. Prepare SDTM data mapping specifications, ADaM dataset specifications, data reviewer’s guides and define.xml documents. Perform QC review of these documents prepared by others. Program SDTM and ADaM datasets according to approved dataset specifications. Generate complete and accurate statistical tables, listings, and graphs (TLGs) in accordance with Statistical Analysis Plan (SAP) and well-defined formats. Document data and programming information in accordance with SOPs and/or clinical trial sponsor’s specific requirements. Perform independent SAS programming validation of datasets and TLGs programmed by others. Perform 3rd level QC review and programmatic checks on programming deliverables before releasing them to clients. Provide training, mentorship, and technical guidance to less experienced Statistical Programmers or Biostatisticians who perform statistical programming. Archive clinical trial data (raw data, SDTM, and ADaM datasets) and programming documentation in accordance with SOPs and/or clinical trial sponsor’s specific requirements. Actively contribute to the continuous improvement of clinical data standards, conventions and statistical programming SOPs. Design and implement SAS macros to enable standardization and efficiency in statistical programming.

Qualifications and Experience:

A Master’s degree in Statistics, Biostatistics, Bioinformatics, Computer Sciences, Mathematics, or other relevant fields is required with at least five years of relevant industry experience using SAS in clinical trial analysis and reporting.  A College English Test (CET) 6 certificate is highly preferred. In-depth knowledge of clinical trial data processing and manipulation, hands on statistical programming and analysis. Knowledge of industry standards on how clinical trial data are structured, stored, analyzed, and presented to regulatory agencies. Knowledge of clinical trial regulatory, ICH GCP, and CDISC requirements. Must demonstrate ability to effectively plan, control, and carry on tasks in SAS programming, statistical analysis, and submission of trial data/results with documentation to regulatory agencies. Strong leadership skills, commitment and drive to achieve goals. This position is expected to perform a leadership role in statistical programming and reporting areas. Incumbents in this role receive highly competitive compensation and benefits. Highly driven, team-oriented, and quality-focused individuals have the potential to advance to technical or business leadership positions.

Tasks are performed in a timely, accurate, and efficient manner to ensure quality and productivity. Deliverables will conform with regulatory submission standards from CDISC, FDA, EMA, CFDA, PMDA, and other regulatory agencies.

Call Cris Murray 416 225-6386, VP Recruitment, J. Edgar and Associates Inc., to apply for this exciting career opportunity.

Please send your CV to me directly for consideration: jedgar@sympatico.ca in either a word or PDF format. Once you submit your CV, I will personally call you back to discuss and disclose our clients details so that you can determine your interest level.


 OPTICAL DEVICES MANUFACTURING ENGINEER - BAY AREA - CALIFORNIA - ABOVE MARKET$

We are currently seeking an experienced Engineer for the manufacturing and production of optical/optics technology components including:  fabrication of parts, components, subassemblies and final assemblies  from developing, implementing and maintaining methods to operation sequence and processes. This position will oversee manufacturing estimates/costs, determining time standards and making recommendations for tooling and process requirements of new or existing product lines.

It is crucial to have experience with formal Optical Manufacturing standards: MIL-PRF-13830 or ISO 10110, ISO 9001 and 13845 Standards as well as a strong Bachelor, Master or Doctorate level degree in Optics or Opto-Mechanical/ Electrical Engineering or applicable Physics and Engineering designations. You must be able to read and interpret mechanical design drawings, electrical schematics and be able to use CAD (Pro-E, ACAD,SWorks, MSProject, Access, SAP-ERP, Visio) tools like ZEMAX to perform modeling and to determine optical tolerance capabilities. This position requires the understanding of laser, optical filter and Photo-Multiplier Tube functions and direct diode lasers.

This position seeks to execute and refine build sequences specific to optics integration, laser optical alignment and system calibrations including evaluating build processes and manufacturing effectiveness for optimal build cycle times and product design specifications. This position will lead efforts in testing and qualifying optical components and modules. Any optics related issues or laser alignment improvements will be part of this mandate. You must be able to solve complex technical issues that require strong understanding of mechanical, optical, electrical and fluidic engineering principles.

We are looking for 7-10 years of Optical engineering experience preferably in Medical Device or Medical Tech with strong cGMP and 21CFR-820 familiarity, DFT Processes (Demand Flow Technology) experience, LEAN, Six Sigma or Black Belt capabilities.

Location: Bay Area, California

Salary: Above Market plus target bonus Plan

Call Jason Edgar at 416 225-2628 for all the details. Please send your CV directly to me for consideration: careers@jedgarcareers.com 


  SENIOR R+D PRODUCT DEVELOPMENT ENGINEER MANAGER-MEDICAL DEVICES-REMOTE AND ONSITE SPLIT WORK WEEK-BAY AREA, CALIFORNIA

We are currently seeking an experienced R+D Engineer with hands on project management experience leading cross-functional teams in product redesign and new product development. This high-profile position is responsible for ensuring the timely development and successful completion of the New Product Introduction sustainability projects portfolio.

The ideal candidate will contribute to improving product development process effectiveness and best portfolio management processes: must have a combination of program and project management including new product development within an R+D setting, preferably in the Medical Device sector with FDA experience or other related Regulatory environment experience.

This role will lead a team of 3 direct reports (remote and onsite) and train the product development teams on Global Product Development System and Process including execution. Will be able to perform skill gap assessment, formulate strategy to address gaps; perform PM training (PMP Certificate preferred) and mentor team. Write meeting minutes and communicate meeting outcomes to relevant stakeholders. Maintain SharePoint sites used by portfolio management team and team leaders. Lead small to medium cross-functional strategic initiatives. Ability to work with business and corporate units with ease.

In this exciting high-profile role, your goal will be to lead and Maintain Visual Management System, KPI’s, track program progress and hold project teams accountable, and publish clear business priorities. This position is designed to attract top talent, offer a platform for high potential associates to gain broad and far-reaching cross-functional business experience and to prepare them for future leadership roles.

Must have 7-10 years of hands-on experience working in R+D and/or Engineering project management leadership teams. Experience OR Knowledge of Flow Cytometry, Sorters and Cell Analyzers will be considered a huge asset.

Education: Bachelor’s degree in Science/Engineering disciplines preferred. PMP Certification preferred.

Salary: Commensurate with experience and higher than average.  15% Bonus and full Health benefits included.

Call Cris Murray 416 225-6386, VP Recruitment, J. Edgar and Associates Inc., to apply for this exciting career opportunity.

Please send your CV to me directly for consideration: jedgar@sympatico.ca in either a word or PDF format. Once you submit your CV, I will personally call you back to discuss and disclose our clients details so that you can determine your interest level.


SENIOR SCIENTIST - IVD REAGENT AND ASSAY DEVELOPMENT - CALIFORNIA

We are currently seeking an experienced IVD ASSAY Development Scientist to join a team of successful Biosciences experts in the pursuit of new Reagent systems. This is a new product R+D role that will act as a Senior resource on the team.

Within this R+D group you will be responsible for initiating and driving reagent and assay development projects and integrating assays and flow cytometry instruments to create the next generation of research and clinical flow platforms; these products include Cell Analyzers, Cell Sorters, Reagents, Assays and their applicable software. Your ability to work with cross functional teams in Engineering and Regulatory Affairs and others, is critical to the mission.

We are looking for a Senior Scientist who maintains a strong understanding of state-of-the-art science and technology development in industry in order to provide leadership and expertise to programs and projects in assigned business areas. This position requires an expert in the design and execution of experiments using applied biological sciences that further the development, verification and evidence generation efforts across assigned projects. Your ability to develop benchmarking studies with competitor assays in order to find improvement opportunities is important.

You must have strong experiences in Immunology in order to develop next generation Cancer screening reagents for the evolution of Flow Cytometry. The goal is to develop assays for specific Leukemia and Lymphoma target diagnostics (IVDs); experience in targeting L+L is important in this role. As SS, you will participate in clinical development programs for the effective introduction of new products, consistent with the strategic R+D plan.

You must have a Master Degree in Immunology with 5 years of Industry experience/Ph.D. +3 Years and possess experience in IVD product development, strong knowledge of processes and measures in R+D including any phase gated development systems, experience in the development of clinical Flow Cytometry assays and instrumentation and knowledge of biostatistical methods and data analysis using current tools(FacsDiva FlowJo Minitab JMP R). This is a 100% R+D Lab based role.

Salary - Above Market - Bonus - 10-15% - Location - San Francisco Bay Area, CALIFORNIA 

Call Jason Edgar at 416 225-2628 for all the details. Please send your CV directly to me for consideration: careers@jedgarcareers.com 


ASSOCIATE OR SENIOR DIRECTOR STATISTICAL PROGRAMMING-REMOTE-USA OR CANADA TO $230K

Our client in Clinical Research is experiencing tremendous growth and as a result this newly created position has become available. We are searching for an experienced Statistical Programming leader to manage a team of like minded Quality driven professionals. This strategic opportunity will lead and manage a group of Statistical Programmers working on phase I-IV clinical trials in most Therapeutic categories.

Bring your technical expertise (Preparing SDTM data mapping specification, ADaM dataset specifications, data reviewer's guides and define .xml documents; perform QC review of documents; generate statistical tables, listings and graphs in accordance with Statistical Analysis plans and formats; ability to perform independent SAS programming validation of datasets; contribute to continuous improvement of clinical standards and SOP's; design and implement SAS macros) combined with your ability to instill a code of conduct to a group of highly educated Statistical Programmers promoting corporate culture and values is key to the success of this role.

Planning and organizing site specific events and activities and working with functional group leaders will be part of your mandate for this exciting high level career opportunity. Overseeing the day-to-day operational effectiveness of the office including liaising with all departments in order to achieve an environment of operational excellence, will be part of the management responsibilities.

Lead deliverable tasks in a timely, accurate and efficient manner to ensure quality and productivity leading study teams by participating in resource planning and managing timelines of project deliverables. Provide training, mentorship and technical guidance to the Statistical Programmers.

A Master's degree in Statistics, Biostatistics, Bioinformatics, Computer Science, Mathematics or other relevant field is required with at least 12 years of relevant industry experience using SAS in Clinical Trial analysis and reporting OR a PhD degree or equivalent in statistical science, Mathematical analysis or related plus 10 years of relevant experience leading teams.

Bring your In-depth knowledge of clinical trial data processing and manipulation, hands on statistical programming and analysis and we can arrange for a meeting of the minds with our client!

Salary: $160-$230K, 10% bonus or 401K and a full and comprehensive benefits package.

Call Cris Murray 416 225-6386, VP Recruitment, J. Edgar and Associates Inc., to apply for this exciting career opportunity.

Please send your CV to me directly for consideration: jedgar@sympatico.ca in either a word or PDF format. Once you submit your CV, I will personally call you back to discuss and disclose our clients details so that you can determine your interest level.


SENIOR SCIENTIST - METHOD DEVELOPMENT, PEPTIDE SYNTHYSIS, SMALL MOLECULE, NEW R&D -WEST COAST USA

We are currently working with a company with a long history of successful Scientific discoveries based on human healthcare needs. This company enables new product Research and Development by teaming great minds and the latest development tools to a specific mission of discovery. This thoroughly inclusive model has allowed the company to build a very strong product portfolio of Medical Devices, Pharmaceutical products and cutting edge Testing and Diagnostic technology.

We are currently seeking a small molecule and peptide synthesis capable Scientist to join a high performance team  on a mission to develop fluorescence dyes for use in Flow Cytometry and other biological applications. Experience with small molecule and macromolecular or polymer separations, purifications and characterizations is key in creating dyes from early proof of concept to formal product development.

Responsibilities: Identify potential new technologies for separation and analytics of fluorescence-based materials. Develop analytical methods from initial feasibility through assessing robustness and capability against desired or current specifications. Design and execute on measurement system analysis (MSA) and Gage R&R studies. Assist with development strategy by interpreting data and providing guidance to product development team being able to speak as a subject matter expert to separation and analytical techniques. Work collaboratively in small teams with chemists, biochemists and applications scientists to establish dye specifications through data driven recommendation. Work within early product pipelines, contributing to various stages of development from early proof-of-concept to process development. Build case for setting dye specifications through statistical processes and data analysis. Perform and oversee a wide variety of small-molecule and macromolecular processing, purification and characterization steps.Draft SOPs, technical reports, and presentations for communicating project progress.

Qualifications: Master Degree with at least 5 years of organic or materials chemistry experience or Ph.D with 1-3 years of industry experience in related field.  Strong diagnostic and analytical skills, experience with HPLC/SEC/IEX chromatography.Experience with UV/Vis and fluorescence spectroscopy. Experience with Six Sigma, MiniTab, or statistical analysis. Efficient with experimental design including statistical approaches such as Design of Experiment (DoE) approach. Some experience with organic synthesis/bioconjugation/materials science is desired. Good organizational and project planning skills. Strong technical writing and team presentation skills to convey findings in order to fulfil formal product design and development.         

Location - US West Coast - Southern California region, Salary - Above market compensation with Bonus plan, 401K plan and thorough health benefits plan.

Relocation - Assistance is provided if required.

Call Jason Edgar at 416 225-2628 for all the details. Please send your CV directly to me for consideration: careers@jedgarcareers.com 


 ASSOCIATE DIRECTOR, DIRECTOR OR SENIOR DIRECTOR OF CLINICAL DATA MANAGERS, WFH, REMOTE, USA-   CANADA                                                                                                                                                                                            

Our client is seeking an experienced Manager, who would like to consider an Associate Director, Director or Sr. Director of Clinical Data Managers career opportunity, managing a group of talented CDM's working on mission critical Clinical Trials in a full service environment in every Therapeutic category.

This high profile role will Develop and manage clinical data management budget and resource plans and perform ongoing assessment and control for utilization of resources and budget.
Manage client project portfolios in conjunction with other corporate executives. Maintain strong client relations. Assist in the development of project bids for new projects.
Assure timely availability of the clinical data capture instruments and databases, and contribute to their completeness, validity, and effectiveness.
Integrate the operations of Clinical Data Management with the requirements of the Quality Assurance, Project Management, Biostatistics, Statistical Programming, and Medical Writing functions to assure cooperative realization of corporate objectives and to optimize the productivity and effectiveness of clinical data management.

Perform competitive benchmarking of clinical data operations to ensure that data management techniques and procedures used are the best in class. Plan, direct, and follow-up on the establishment of data management guidelines and procedures which are in line with industry good data management practices. Participate in and contribute to the corporate efforts in investigating, establishing and implementing new and advanced systems, standards, and procedures to improve the effectiveness of data capture and management. Train, motivate, monitor and develop staff to assure high levels of performance with strong professional and technical expertise. Complete annual and semi-annual performance reviews. Plan, implement, and oversee staff training and development process.

Planning and implementing data management timelines and deliverables and contributing to the overall project planning, progress tracking and reporting. Perform study resource planning, budgets and design and review case report forms (CFR's/eCFR's). Assist in performing client relationship management activities and participate in project bid defense meetings as required.

Participate in Project kick off meetings, investigators meeting and similar. Review Data, issue and resolve queries; assist in resolving medical coding discrepancies. Manage EDC, CRF to PDF CRF conversion process for generating regulatory submission ready CRF packages.

Qualifications and Experience:

A Bachelors or Master's degree in Health and/or Pharmaceutical Sciences, Physical/Biological or Chemistry fields.

Five years working as a Clinical Data Manager and at least 2 years managing teams of CDM's. Demonstrated an in-depth understanding of Clinical Trial Data Management concepts, processes and procedures, relevant issues related to or impacting Clinical Data Management, as well as Pharmaceutical Clinical Trial Regulations, Industry guidance, conventions and standards.

Demonstrated a strong  leadership in Clinical Data Management activities and a desire to excel in leading Data Management projects. Superior English communication skills are considered an asset!

Compensation: Higher than average, and commensurate with experience, bonus, Benefits and Pension.

Start date: ASAP

Call Cris Murray 416 225-6386, VP Recruitment, J. Edgar and Associates Inc., to apply for this exciting career opportunity.

Please send your CV to me directly for consideration: jedgar@sympatico.ca in either a word or PDF format. Once you submit your CV, I will personally call you back to discuss and disclose our clients details so that you can determine your interest level.


SENIOR DIRECTOR AND VP LEVEL CLINICAL DEVELOPMENT/OPERATIONS-CANADA OR USA-REMOTE

We are currently seeking two (2) committed, skilled, and customer-focused professionals to join an award winning team as Clinical Operations Leaders to develop and lead the Clinical Operations teams in a highly successful, full service, Clinical Research Organization specializing in every Therapeutic category from Phase I-IV. Bring your superior communication skills, quality deliverables, stellar customer service, and flexibility in meeting clients needs, and we have a dynamic career opportunity awaiting your exploration!

The Clinical Operations Leads serve as the clinical functional leads, accountable for the site management/clinical monitoring delivery of assigned tasks and projects as per scope. Will provide clear oversight and coordination of working across regions to ensure clinical project and site deliverables are met. Bring your leadership, mentoring, and technical support to the Clinical Operations team to ensure quality deliverables and achievement of milestones and financial goals. These high-profile roles will be responsible for tracking study progress and assessing compliance of the conduct of clinical trials with regulatory requirements, the clinical study protocol, study-specific plans, and Standard Operating Procedures.

In these customer facing roles, you will interact with Study Sponsors, Investigational sites, vendors and other functional departments related to site management and clinical monitoring activities to ensure timely and high-quality deliverables at all times. Ensure quality visibility of its progress through CTMS/eTMF and/or tracking tools. Review study scope of work, budget and protocol content and ensure the Clinical Operations team are aware of the parameters. Ensure alignment of clinical activities to budget, including identification of out-of-scope activities. Escalate to Project Managers any clinical/site management deliverables (timeline, quality, and budget) at risk, and any activities or requests which are out of contracted scope.

Develop, train, mentor, and guide clinical operations team on protocol specific plans, guidelines and timelines, with support from Clinical Operations Oversight, Project Management, Medical Monitoring, and Sponsors, to foster a team culture that supports the Clinical Operations team and results in staff retention. Coach and Mentor Clinical Operations Leads regarding functional clinical delivery, evaluation of project risks, and action-oriented implementation. Set priorities for the teams to complete and manage on a regional and site level. Participate in scheduled Study Management Team meetings for assigned projects, provide status updates and are accountable for deliverables. Organize and Lead CRA team meetings to provide study updates and perform training as needed. Author the Monitoring Plan and accountable for the Clinical Operations teams (scheduling and report submission/finalization) to ensure compliance with the Monitoring Plan and understand the monitoring strategy by providing technical expertise. Liaise across various clinical stakeholders to compile reports to track progress and performance metrics.

Act as point of contact for clinical site monitoring and Investigator site questions/issue escalation. Perform site management, review report progress status of the investigational sites. Communicate directly with sites to provide direction, assess performance, and propose alternatives to enhance performance of patient enrollment and data submission. Issue periodic clinical trial Newsletters when required.

May conduct co-monitoring/preceptor oversight visits with CRA’s to evaluate staff’s ability and performance level. May perform Pre-Study, Site Initiation, Interim Monitoring/Remote, and or Closeout Visits as required.

Lead site feasibility and selection process. Support review of the documentation (review informed consent forms) to ensure clinical site comply with ICH-GCP and relevant regulations. Assist with negotiation of sites, contracts/budgets and prepare payments for Vendors/investigational sites. Assist with Preparation and submission of regulatory documents to regulatory agencies, authorities, IRBs and Research Ethics Committees. Collaborate with functional teams including Medical Monitoring, Pharmacovigilance, and Quality Assurance to ensure site compliance. Prepare, maintain and complete training on study specific sponsor SOP’s. May participate in Business Development activities including strategy, budget input and proposal development.

Equipment/Software: Microsoft Software (Word, Excel, PowerPoint, Project, Outlook, Calendar, Contacts, and Tasks). Knowledge of database systems, including Oracle InForm, MediData Rave, DFdiscover and other Electronic Capture systems. Flex Database Trial Master File and Clinical Trial Management System.

Qualifications include: Minimum BSc in life sciences or related field, MSc and/or MBA preferred. At least 6-15 years of Clinical Research Trial and/or monitoring experience. Thorough knowledge of ICH-GCP guidelines + regulations, and comprehension of medical terminology. Must have experience leading and managing groups within a CRO, Biopharmaceutical setting.

Energized, polished and ready for your next challenge, please call today!

Salary: above market, highly competitive. Bonus 10-15%, full and thorough benefits package, long term incentive plan!

Location: Canada and/or USA, remote.

Call Jason Edgar at 416 225-2628 for all the details. Please send your CV directly to me for consideration: careers@jedgarcareers.com


DIRECTOR/SENIOR DIRECTOR BIOMETRICS, BIOSTATISTICS, CLINICAL RESEARCH CANADA OR US HOME BASED TO $250K

Our growing, successful quality focused Clinical Research client is seeking a Senior Director of Biostatistics to manage the daily activities of the Biostatistics staff to ensure everyone is well-trained on SOP's and to promote efficiency, quality and timelines in all project deliverables.

Bring your technical expertise, positive personality and business savvy nature to the table and we have found you a match. Our client is looking for a dedicated communicator, senior leader who is ready for their next challenge. You will lead, guide, build and maintain key client relationships; be responsible for departmental growth and development, including budgeting, forecasting and proposal development. Mentoring and leading Biostatistics departments for all clinical phase 1-4 projects will be the main focus of this career opportunity.

Key Accountabilities:

  1. Provide leadership and expertise in resolving complex operational and technical problems in support of division/company objectives and projects, or as a resource to others. Maintain expertise in industry norms, trends across biometrics and regulatory requirements.

  2. Provide supervision to ongoing projects by applying management skills, regulatory standards and requirements, and quality management to ensure quality and timely deliverables.

  3. Build and maintain relationships with assigned clients to ensure biometrics services are well represented and that communication with the client and the functional teams are clear.

  4. Represent biometrics for the company in external business development, regulatory or industry consortiums.

  5. Represent biometrics functional service group in external and internal audits, as well as qualification/maintenance audits for vendors contracted.

  6. Monitor and assess the progress status of ongoing projects. Ensure high quality standards, on time delivery within budget for all stages of the clinical trials – from the trial design, protocol development, statistical analysis planning and execution, to the writing of statistical sections of the Clinical Study Reports or the generation of publications of trial results.

  7. Support cross-functional biometrics process development, making multi-disciplinary teams more effective by utilizing the strengths of each biometrics functional team.

  8. Provide leadership and expertise in day-to-day statistical operations and development of statistical methodologies to solve practical statistical problems.

  9. Serve as a principal level biostatistician, working effectively with interdisciplinary teams to contribute to drug development at the study and drug compound levels. Provide statistical consultation to trial medical/clinical personnel when required.

  10. Participate in development of study concepts and study protocols.

  11. Lead statistical and programming teams on assigned projects. Plan and manage resources, timelines, and quality of statistical and programming deliverables.

  12. Perform planned, ad hoc, and/or exploratory statistical analyses.

  13. Write Statistical Analysis Plans, Statistical Reports, and statistical methodologies sections of Clinical Study Reports, publications, abstracts, posters, presentations, etc. Review statistical documents generated by others.

  14. Perform independent validation of statistical results generated by others and perform third level Quality Control review on statistical and programming deliverables before they are released to the clients.

  15. Interact with regulatory agencies and support client in New Drug Applications/Biologic License Applications. This includes participating as a statistical liaison to the regulatory agency on behalf of the client and ensuring documentation, statistical results, and study datasets meet the regulatory agency’s requirements and expectations (e.g., CDISC).

  16. Mentor and supervise direct and indirect subordinates. Perform semi-annual and annual performance reviews and prepare developmental plans for direct subordinates and indirect subordinates, where appropriate, through contributing to the performance evaluation process.

  17. Plan and manage resourcing plans by working with the Project Management group in forecasting resource needs relative to the roles of the personnel. Proactively and continually update the plan with changes to demand, and identify/solution resourcing gaps or overage.

  18. Participate in recruiting and staffing for responsible functional area, as well as coaching, mentoring, and developing staff members.

  19. Contribute to the company’s management team function and activities.

Qualifications and Experience:

  1. A Ph.D. degree in statistical science, mathematical analysis, or related fields with at least 12 years of relevant experience or a Master’s degree in these fields with at least 15 years of relevant experience.

  2. Minimum of 4 years managing people, with demonstrated exceptional ability and performance.

  3. Significant contribution, and/or outstanding/sustained performance may be used in lieu of the requirement on the number of years of relevant experience.

This high level position reports into a senior executive who reports into the President. Work in tandem with a strong team to reach new heights in Clinical Research and have the autonomy to act as a business owner with an entrepreneurial spirit.

Salary: $180-$250, 401K, bonus and full benefits package. WFH career opportunity.
Please call Cris Murray 416 225-6386, VP Recruitment, 416 225-6386.  Please send your CV directly to me for consideration: jedgar@sympatico.ca 

MANAGER OF STATISTICS CLINICAL AND PRODUCT DEVELOPMENT STATISTICS - MEDICAL DEVICES – REMOTE - USA OR CANADA – ABOVE MARKET COMPENSATION - BONUS +FULL BENEFITS

We are currently working with an International Medical Device Manufacturer with a long history of successful operation looking to expand their Statistics Management department with a Lead Biostatistics Manager. Bring your hands on professional Clinical Study lead experience with clinical and product development, and we have a new and exciting challenge for you.

We are currently seeking a Senior Global Statistician Manager with Clinical Study lead experience working and managing a team of up to 6 professional Statisticians across Europe and North America.

Ideally based in either Eastern or Central time zones to enable cross management and facilitation of project deliverables, the ideal candidate will lead, collaborate, select external vendors, budget and provide vendor oversight with a positive, professional personality.

We are looking for a unique combination of adaptive designs for clinical trials and leadership, providing improved sample sizing for product design verification including Meta-analyses to combine and leverage disparate sources of data and provide novel statistical methods.

Striving for continuous improvement and added value by developing innovative methods to increase efficacy and efficiency. Identify new opportunities to reduce development costs and timelines while maintaining the highest levels of Quality simultaneously.

Leading the development and maintenance of the statistics department to achieve companies strategic objectives and actively participate in the development would be part of the responsibilities for this role.

Must have: BSc minimum, preferably a MS or PhD welcome in either Statistics, Mathematics or similar plus 6 years (either pharmaceutical, medical device or CRO) of hands on experience in industry with  demonstrated advanced experience in clinical development in biostatistics, with regards to development and implementation of advanced methods (adaptive design, Bayesian statistics, missing data), along with QA statistical knowledge to support new product development, e.g. DOEs, Statistical intervals, predication models, simulations.

Excellent skills in SAS and R with a track record of clinical trial development and execution in alignment with regulatory and/or pricing requirements as well as project leadership. Expert in the application of the state-of the-art statistical methodology in all projects.

Excellent interpersonal, written, communication, analytical, and organizational skills with creative approaches to information systems issues and problems. Working knowledge of RWD/RWE experience, clinical trials, product development and relevant regulatory guidelines will propel your career top new heights.

Salary: Above market compensation with bonus and full and comprehensive benefits package.

Call Cris Murray for all the details at: 416 225-6386.  Please send your CV directly to me for consideration: jedgar@sympatico.ca 


TEAM LEAD - NEXT GEN ANTIBODY REAGENTS - NEW PRODUCT R+D - US WEST COAST

We are currently supporting a global leader with a long history of successful Scientific discoveries based on human healthcare needs. This company enables new product Research and Development by teaming great minds and the latest development tools to a specific mission of discovery. This thoroughly inclusive model has allowed the company to build a very strong product portfolio.

We are currently seeking a Senior Scientist to lead a Team in the development of next generation Antibody Reagents and R+D line extension product development. The company has strong success in Reagent development to date and through this high performance Life Sciences R+D team, they will enhance existing products and build on that development to develop new Reagents.

Responsibilities: Lead a team to assess feasibility and viability of new antibody reagents. Serves as a resource to team level scientists to guide experimental design and analysis of Flow Cytometry experiments. The Team Lead will contribute to the completion of milestones associated with specific projects. As part of the process improvement group in new product R+D, transitioning assays from manual to automated workflows is a goal. As part of the planning and project management leadership team, you will participate in functional and cross-functional training to advance technical capabilities of the New Product development team. This position requires the ability to critically analyze and interpret data and provide feedback and guidance to team members. As Supervisor, you must be proficient in promoting a safe and compliant work environment.

Qualifications and Skills: Master Degree in Immunology or a life science discipline with 6 years’ experience developing antibody reagents and operating a flow cytometer OR Ph.D with 4 years of combined industry and academic experience in flow cytometry component of antibody reagent development. Minimum of 4-6 years’ experience designing, performing, and analyzing flow cytometry experiments, preferably on X20, FACSymphony, Lyric, Canto and Aria flow cytometers. Workflow automation and Process Improvement experience is a strong asset for this role.

Strong understanding of flow cytometry principles and instrumentation and optimizing flow cytometer settings is preferred as well as solid experience with Flow Cytometry Data analysis tools. Strong general Laboratory skills and strong knowledge of immunology are required in this role. Excellent oral and written communication skills as well as a history of project management experience and strong analytical problem-solving skills is required in this role. This position requires an organized self starter with demonstrated organizational, time management, and planning skills to efficiently prioritize and manage multiple projects.

Location - US West Coast - Southern California region

Salary - Above market compensation with Bonus plan, 401K plan and thorough health benefits plan.

Call Jason Edgar at 416 225-2628 for all the details. Please send your CV directly to me for consideration: careers@jedgarcareers.com


BIOTECH PHARMACEUTICAL MATERIALS MANGEMENT SCIENTIST, NEW JERSEY

We are currently seeking an experienced Materials Scientist to manage materials and consumables for a global biotech leader. This position is responsible for providing technical oversight of raw materials and consumables utilized during the manufacture of monoclonal antibodies and fusion proteins to ensure the reliable supply of material with safety first and quality always.  Scope of work includes qualification, implementation, continuous improvement, investigation support and technology transfer.   This position will interact with Engineering, Manufacturing, Validation, Quality Assurance, Quality Control, Procurement, Regulatory departments, other sites and external suppliers.  Knowledge of cell culture, purification and the support systems used in the manufacture of biotech products is required.

Responsible for supporting manufacturing operations through the performance of the following duties:

Provide technical support and expertise for the qualification and implementation of new raw materials and consumables. Work effectively and efficiently in a cross-functional team with Quality Control, Quality Assurance, Operations Planning, and Procurement to ensure reliable supply of raw materials and consumables.

Lead technical evaluations of second sources of key raw materials and consumables to firm up supply chain Provide technical support during the evaluation of supplier change notifications (SCN). Own extractable and leachables risk assessments as needed to support commercial manufacturing. Provide technical support and ownership for the qualification and monitoring of working cell banks.

Anticipate and resolve complex problems.  Drive solutions that impact the site.

Lead medium to large scale projects or programs with moderate risks.  Requires comprehensive business and technical knowledge to improve products or processes.

Build relationships with internal and external partners.

Provide technical review and input for protocols and reports, both within and external to Technical Services/Manufacturing Science (TS/MS).

Author Standard Operating Procedures SOPs as they relate to the activities of TS/MS.

Understand and perform all job responsibilities in compliance with safety and regulatory expectations, as well as, cGMP.

Basic Qualifications:

BS degree in Biochemistry, Chemistry, Bio/chemical engineering or related science

Minimum of 5 years experience in a cGMP biopharmaceutical or pharmaceutical manufacturing and/or development environment.

USA - New Jersey - Great Company - Above Market Compensation Package - Full benefits - Relocation Assistance. Relocation Assistance can be offered.

Salary - Above Market and commensurate with experience.

Call Jason Edgar for all the details at: 416 225-2628. Please send your CV directly to me for consideration: careers@jedgarcareers.com


SENIOR BILINGUAL CLINICAL RESEARCH ASSOCIATE TO $120K, PLUS 10% BONUS, CAR ALLOWANCE, FULL BENEFITS. WORK FROM HOME

Our client, specializing in Clinical operations is searching for a Senior Bilingual Clinical Research Associate where you will be responsible for monitoring, reporting, tracking study progress, and assessing compliance of the conduct of clinical trials with regulatory requirements, the clinical study protocol, study-specific plans, and Standard Operating Procedures. 

The role includes leadership of the Clinical Operations study team as well as assessment and direction of other Clinical Operations staff assigned to studies.  We are looking for an interactive team player who knows how to work with study sponsors, investigational sites and vendors to enable timely and high quality initiations and completions of Clinical Trials. Our client needs your ability to identify, evaluate and qualify investigators and investigational sites for participation in clinical trials.

Your ability to compile documentation for qualification of clinical sites and ensure they are compliant with ICH-GCP and relevant local regulatory bodies will enable your success in this newly created role.

Bring your keen sense of contract negotiations to collectively participate in and prepare presentations for clinical trials initiation meetings and or training sessions.  Perform on-site monitoring of clinical studies and document monitoring activities through submission of monitoring reports to Clinical Operations management for review.  Responsible for site management.

Requirements: Bachelors degree in Life Sciences or Health related field.  Minimum of 5 years of experience in monitoring clinical trials in the field required.  Excellent written and oral presentation skills, thorough knowledge of GCP's and ability to travel to local study sites up to 40%.

Salary: $120K.

Bonus: 10% annual bonus, car allowance and other relevant expenses plus full health benefits package, RRSP contribution and 4 weeks paid vacation.

Call Cris Murray for all the details at: 416 225-6386.  Please send your CV directly to me for consideration: jedgar@sympatico.ca


DIRECTOR OR SR DIRECTOR OF CLINICAL DATA MANAGERS, REMOTE, PLUS BONUS, BENEFITS AND INCENTIVES TO $160K

We are currently seeking an experienced leader to manage a group of talented Clinical Data experts working on mission critical Clinical Trials in every Therapeutic category.

In this leadership role, the incumbent will develop and manage a clinical data management budget and resource plans while performing ongoing assessment and resource management of the group. As Director, you will Manage client project portfolios as part of a full service team of management leaders. This position requires maintenance of strong client relations and assisting in the development of project bids for new projects.

As Director, you will assure timely availability of the clinical data capture instruments and databases, and contribute to their completeness, validity, and effectiveness. In this position, the incumbent will work to integrate the operations of Clinical Data Management with the requirements of the Quality Assurance, Project Management, Biostatistics, Statistical Programming, and Medical Writing functions to assure cooperative realization of corporate objectives and to optimize the productivity and effectiveness of clinical data management.

The Director will; perform competitive benchmarking of clinical data operations to ensure that data management techniques and procedures used are the best in class, plan, direct, and follow-up on the establishment of data management guidelines and procedures which are in line with industry good data management practices, train, motivate, monitor and develop staff to assure high levels of performance with strong professional and technical expertise. Completing annual and semi-annual performance is also within the responsibility of the Director.

Qualifications and Experience:

A Bachelor or Master degree or higher in: Clinical Research Management, Pharmacy or Pharmaceutical Sciences, Epidemiology or HealthCare Management, Statistics or Biostatistics, Mathematics, Biology or Chemistry fields or a similar Research science based degree.

Five years working as a Clinical Data Manager and at least 5 years leading teams in Clinical Data Management. We are looking for a demonstrated in-depth understanding of Clinical Trial Data Management concepts, processes and procedures and relevant issues related to or impacting Clinical Data Management, as well as Pharmaceutical Clinical Trial Regulations, ICH - GCP compliant to the FDA, Health Canada and other global regulatory bodies.

Compensation: commensurate with experience in the $140-160K range plus bonus, benefits and other incentives. Start date: ASAP

Please call me directly 416 225-6386 and please send your updated Resumes for consideration. Thank you, Cris Murray, jedgar@sympatico.ca


PROPOSAL WRITER FOR CLINICAL DRUG RESEARCH PROJECTS, TO $100K, PLUS FULL BENEFITS, PENSION AND BONUS, REMOTE CANADA OR US

We are currently seeking an experienced Clinical Research Proposal Writer or Manager.

We are looking for good experience responding to RFIs and practical Costing estimates. Join an established firm with a reputation for high quality Clinical Research project delivery and work with the biggest and the most innovative R+D global pharmaceutical firms.  Strong communication skills and costing/budgeting experience is required in this role.

The details:

1. Prepare and complete RFI’s and RFPs upon assignment including initial set-up of the key deliverables outlining quality-control and compliance adherence to meet Regulatory Agency approvals. Amalgamation of costing sheets to disclose the financial estimates of each study project. Ensure final proposal documents are edited and thoroughly proofread.
2.  Prepare costing and precise Project deliverables for various types of clinical trial studies in Ph1-IV development.                                                                                                                       

3. Use business analysis skills and work with internal stakeholders to assess and seek efficiencies in processes to achieve cost effectiveness in each study project.
4. Manage and track inflow and outflow of all RFI’s and RFP’s in conjunction with Senior Management and establish cut-off dates/timelines that identify the expected completion date for each Request or Proposal.
5. Write Project proposals for study budgets as final deliverable for client as per SOPs.

Education and Skills:  BS, BA (plus MA, MS or MBA would be an asset) in any related discipline: Science, Communications, Business/Finance, Accounting, Engineering.

  • Background in clinical research/health care, Pharmaceutical organizations or CRO's 
  • At least 4-6 years experience in the preparation of proposals, bids and quotes.

Please call Jason Edgar 416 225-2628 for all the details.


ASSOCIATE DIRECTOR/DIRECTOR STATISTICAL OPERATIONS WFH OR TORONTO BASED, TO $ 200K BASE PLUS BONUS, BENEFITS

This position functions as a technical and operational leader interfacing with clients and leading internal statistical and programming teams to achieve clinical development project/program objectives. The accountabilities of this position are described below.

 1.     Work with a Director, Senior Director, and/or Executive Director of Statistical Operations to manage clinical trial programs/projects from one or multiple clients. Provide day to day technical and operational leadership to project teams supporting these programs/projects.

2.     Coach, mentor, develop, provide technical review, advice and expertise to direct subordinate Biostatisticians and Statistical Programmers as well as indirect subordinate Biostatisticians and Statistical Programmers assigned to the program/projects.

3.     Perform semi-annual and annual performance review and develop developmental plans for direct subordinates and, where appropriate, indirect subordinates through contributing to the performance evaluation process.

4.     Provide statistical oversight on projects in the assigned drug development programs/projects, ensuring sound statistical methodologies in study design, sample size estimation, statistical analysis planning, statistical modeling, data handling, analysis and reporting.

5.     Provide statistical input in protocol design and development. Participate in the writing of trial protocols and research proposals.

6.     Serve as a principal level Biostatistician, working effectively with interdisciplinary teams to contribute strategically (through innovative ideas or applications) to drug development and commercialization at the study and drug compound/therapeutic areas levels.

7.     Review and provide input to clinical data management deliverables, including but are not limited to the following: eCRFs, eCRF Completion Instructions, data validation specifications, Data Review Plan (and the ongoing data review tables, listings, and figures in accordance with the Plan), and Data Management Plan.

8.     Write Statistical Analysis Plans, Statistical Reports, and statistical methodologies sections of Clinical Study Reports. Perform peer review of SAPs and other technical documents written by others.

9.     Perform hands on statistical analysis and modeling, and maintains expertise in state-of-the-art statistical methodology and regulatory requirements.

10.  Validate core statistical tables, listings, and figures programmed by statistical programmers and/or biostatisticians, ensuring that core results for each responsible trial are complete and accurate. Perform overall Quality Control review on statistical deliverables before they are released to the clients.

11.  Review and confirm ADaM dataset specifications. Perform quality control activities on ADaM datasets programmed by other statistical programmers and biostatisticians.

12.  Provide statistical consultation to medical and clinical trial personnel for the publication of trial results, and participate in the writing of abstracts, manuscripts, posters, and presentations.

13.  Act as a consultant to less experienced biostatisticians.

14.  Ensure all study level as well as drug program level statistical and programming activities are conducted in compliance with relevant regulatory requirements and applicable standards/conventions.

15.  Interact with regulatory agencies and support sponsor in new drug application. This includes participating as a statistical liaison to the regulatory agency on behalf of the sponsor company and ensuring documentation, statistical results, and study datasets meet the regulatory agency’s requirement/expectation (e.g. CDISC).

16.  Perform statistical and programming resource management, capacity analysis, benchmarking and metrics. Participate in the continuous improvement and maintenance of statistical and programming governing documents.

17.  Contribute to organization development and growth by participating in the interview and evaluation process for professional applicants.

 Qualifications and Experience:

 A Ph.D. or Masters degree in statistical science, mathematical analysis or related fields with 10 + years of relevant experience.

 Cris Murray 416 225-6386 for all the details. Please send your CV directly to me for consideration: jedgar@sympatico.ca


BIOSTATISTICIAN WORK FROM HOME ANYWHERE IN USA TO $200K, 401K AND FULL BENEFITS

We are searching for several senior talented Biostatisticians who will be accountable for developing, applying and/or providing expertise in clinical trial statistical and programming methods and techniques to effectively manage and complete statistical and programming projects, and to support the company’s mission, strategies, customers and priorities. In addition to the technical accountabilities, this position assumes project management responsibilities in directing and managing statistical and programming team activities for clinical trials from the development of study protocols to the completion of study reports. May represent division and the company, participate in business development and customer relationship management activities, and provide leadership in executing divisional and corporate plans.

  1. Provide leadership/expertise in day to day statistical and programming team operations and in resolving complex problems for assigned projects, or as a consultant to others. 

  2. May represent division or company - provide leadership in major divisional/corporate efforts and in executing divisional or corporate plans. These efforts may include, but not limited to, the following:
    - Providing leadership/expertise in research and development of statistical methodologies.
    -  Investigating and implementing new technologies, processes and procedures.
    - Developing and executing customer relationship management plans.
    - Participating in new business development and bidding processes.

  3. Act as Lead Biostatistician/Teammate Biostatistician to interact with clinical trial sponsor companies, and oversee projects for a sponsor company and/or for given therapeutic areas.

  4. Lead assigned projects by applying project management skills, statistical and programming techniques to deliver quality and timely deliverables.

  5. Plan, develop and monitor timelines for statistical and programming activities in accordance with medical/clinical activities for assigned projects. Jointly with immediate management, assess statistical and programming resource needs and manage the assigned resources to the projects.

  6. Write Statistical Analysis Plans (SAPs) for assigned projects. Perform review on the SAPs written by others.

  7. Provide statistical input into the development of study concept, protocol synopsis, protocol, and protocol amendments.

  8. Perform review of clinical trial documents, including but not limited to the following: study concept sheet, protocol synopsis, protocols and amendments, statistical and programming documents generated by others, and clinical study reports or publications. 

  9. Develop or perform review of statistical programming technical specifications, which include but not limited to the following: clinical trial data handling rules, statistical derivations/algorithms, SDTM and ADaM dataset specifications, and statistical testing/modeling approaches.

  10. Perform quality control (QC) activities on statistical datasets such as SDTM and ADaM datasets. These activities include but not limited to the following: perform independent statistical programming to validate the datasets, perform QC review of the datasets, assess and recommend resolutions on discrepancies between the datasets generated by two Statistical Programmers or Biostatisticians.

  11. Perform quality control (QC) activities on statistical analysis results or data displays such as statistical summary tables, listings, and graphs (TLGs). These activities include but not limited to the following: perform independent statistical programming to validate the TLGs, perform QC review of the TLGs, assess and recommend resolutions on discrepancies between the results generated by two Statistical Programmers or Biostatisticians.

  12. Generate or perform QC on clinical trial patient randomization codes and treatment assignments. Oversee IxRS (IVRS and IWRS) implementation of patient randomization codes and treatment assignments for assigned projects.

  13. Provide statistical and programming input into clinical trial Case Report Forms (CRF) design for assigned projects, and may provide input to the database design data flow, variable naming conventions and data structure, etc. when required.

  14. Participate in clinical trial kick off meeting, investigators meeting, and ongoing trial management team meetings as per project requirements.

  15. Write statistical and results sections of the Clinical Study Report, or perform QC review of the CSR.

  16. Provide statistical and programming support to clinical trial results dissemination activities, such as generation of data reports for abstracts, manuscripts, posters, and presentations, etc.

  17. With assistance from the Archivist, archive study documentation upon the completion of final Study Reports.

  18. Participate and contribute to the training, mentoring, and development of new Biostatisticians or Statistical Programmers.

  19. Adhere to company governing documents (policies, SOPs, work instructions, templates and checklists), may contribute to the further development of these documents.

  20. Contribute to organization development and growth by participating in the interview and evaluation process for job applicants.

  21. Plan and carry out professional development.  

Qualifications and Experience:

A Ph.D. degree or equivalent in statistical science, mathematical analysis or related plus 3 years of relevant experience or a Master’s degree plus 4 years relevant experience with demonstrated ability and sustained performance at the Ph.D. level.

Please call Cris Murray 416 225-6386 for all the details. Please send your CV directly to me for consideration: jedgar@sympatico.ca

STATISTICAL PROGRAMMER-INTERMEDIATE OR SENIOR-WFH ANYWHERE IN CANADA AND US, BONUS PLUS BENEFITS

We are currently seeking experienced Statistical Programmers at Intermediate and Senior levels.

Good communication skills and a can do attitude will gain you access to a growing team of Biostatisticians and Statistical Programmers at an award winning, high delivery quality firm.

As Statistical Programmer you will: Perform data conversion between datasets with two different formats according to conversion requirements/specifications, conversion of Excel data records to SAS datasets, non-CDISC compliant datasets to CDISC compliant datasets. You will assist in developing SDTM data mapping specifications. Program SDTM and ADaM datasets according to approved dataset specifications. Generate complete and accurate statistical tables, listings and graphs (TLGs) in accordance with Statistical Analysis Plans and well defined formats. Develop and test SAS programming codes for clinical trial database logical checks and data reports for ongoing data review. Perform SDTM CRF annotation or QC activities on aCRFs generated by others. Document data and programming information in accordance with SOPs and or clinical trial sponsor specific requirements as well as archiving clinical trial data (raw data, SDTM and ADaM datasets) and programming documentation.

Requirements and Qualifications: A Master Degree in Statistics, Biostatistics, Bioinformatics, Computer Science or Mathematics with at least 1-3 years experience using SAS. SAS certification is an asset and preferred. Must have experience includes the ability to perform data conversion between datasets with two different formats according to conversion requirements/specifications.

Most importantly, you should have experience with all elements of the work you will perform; detailed above.

Salary - Commensurate with experience, higher than average salaries with Bonus, benefits and pension!

Location - GTA, Start - October - 2020

Please call Jason Edgar 416 225-2628 for all the details. Please send your CV directly to me for consideration: careers@jedgarcareers.com


SENIOR TO PRINCIPAL BIOSTATISTICIANS TORONTO BASED OR WORK FROM HOMEOUTSIDE OF GREATER GTA TO $140K, PLUS 10% BENEFITS, PENSION

We are searching for several junior to intermediate talented Biostatisticians who will be accountable for applying and/or providing expertise in statistical, programming, and data management methods and techniques to effectively enable decision making in support of the company’s mission, strategies, customers and priorities. Key responsibilities: Lead efforts in resolving day to day work related issues and problems, improving efficiency, quality, and productivity of the operation; enhancing customer relationships and improving customer satisfaction. Research and development of statistical methodologies. Investigate and implement new technologies, processes and procedures. Participate in developing and executing marketing strategies and participate in developing and executing customer relationship management plans. Participate in business development and maintenance activities. Perform review for clinical study protocols and statistical, programming, and data management documents generated by others.

  1. Lead assigned projects by applying project management skills, statistical, programming, and data management techniques to facilitate better decision making, improve business operations and discover, improve, develop or defend new or existing products.
  2. Plan, develop and monitor timelines for statistical, programming, and data management activities in accordance with medical/clinical activities for assigned projects. Jointly with immediate management, assess statistical, programming, and data management resource needs and manage the assigned resources.
  3. Provide statistical and data management input into protocol development. Write Statistical Analysis Plans for assigned projects. Oversee IVRS and web-based patient randomization processes for assigned projects.
  4. Oversee the development of Data Management Plans (DMPs) for assigned projects.
  5. Provide statistical input into Case Report Forms (CRF) design for assigned projects, and oversee efforts in developing, reviewing and testing of the CRFs.
  6. Provide statistical and programming input into database design for assigned projects, and oversee efforts in development, validation and testing of the study databases.
  7. Participate in Study Manual Development, and in clinical trial initiation meetings such as investigator meetings, site monitor/coordinator training sessions. Address statistical, programming, and data management questions/concerns from the meeting participants. Train site personnel on data management requirements and procedures.
  8. Oversee data management and programming activities for assigned projects. Serve as primary contact between medical/clinical and data management in data related issues.
  9. Oversee programming support activities for assigned projects. Validate the accuracy, consistency and integrity of the statistical output displays generated by the Study Programmer.
  10. Perform statistical data analyses. Write statistical and data management sections of the joint medical and statistical Study Reports for assigned projects.
  11. With assistance from the Archivist, archive study documentation upon the completion of final Clinical Study Reports.
  12. Participate in evaluating the performance of assigned project personnel.
  13. Follow up on the development and implementation of new statistical, programming, and data management methodologies which will improve current/future decision making or divisional/corporate business processes, and on the statistical/data management related regulatory requirements and practices.
  14. Participate in the development and maintenance of, and adhere to divisional SOPs and guidelines.
  15. Participate in the development and maintenance of, and adhere to therapeutic area specific standards and conventions.
  16. Participate in the development and maintenance of, and adhere to corporate policies and SOPs.
  17. Plan and carry out professional development.

Qualifications and Experience:

A Ph.D. degree or equivalent in Statistical Science, Mathematical Analysis, or related field plus 1 to 2 years relevant experience or a Master’s degree plus 4 to 5 years relevant experience with demonstrated ability and sustained performance.

Cris Murray 416 225-6386 Email resume in Word format to: jedgar@sympatico.ca


MANAGER OR ASSOCIATE DIRECTOR OF CLINICAL DATA MANAGERS TO $140K PLUS BONUS AND BENEFITS 

Our client is seeking an experienced Manager or Associate Director of Clinical Data Managers, managing a group of talented CDM's working on mission critical Clinical Trials in every Therapeutic category.

This high profile role will Develop and manage clinical data management budget and resource plans and perform ongoing assessment and control for utilization of resources and budget.
 Manage client project portfolios in conjunction with other corporate executives. Maintain strong client relations. Assist in the development of project bids for new projects.
 Assure timely availability of the clinical data capture instruments and databases, and contribute to their completeness, validity, and effectiveness.
Integrate the operations of Clinical Data Management with the requirements of the Quality Assurance, Project Management, Biostatistics, Statistical Programming, and Medical Writing functions to assure cooperative realization of corporate objectives and to optimize the productivity and effectiveness of clinical data management.

Perform competitive benchmarking of clinical data operations to ensure that data management techniques and procedures used are the best in class. Plan, direct, and follow-up on the establishment of data management guidelines and procedures which are in line with industry good data management practices. Participate in and contribute to the corporate efforts in investigating, establishing and implementing new and advanced systems, standards, and procedures to improve the effectiveness of data capture and management. Train, motivate, monitor and develop staff to assure high levels of performance with strong professional and technical expertise. Complete annual and semi-annual performance reviews. Plan, implement, and oversee staff training and development process.

Responsible for planning and implementing data management timelines and deliverables and contributing to the overall project planning, progress tracking and reporting. Perform study resource planning, budgets and design and review case report forms (CFR's/eCFR's). Assist in performing client relationship management activities and participate in project bid defense meetings as required.

Participate in Project kick off meetings, investigators meeting and similar. Review Data, issue and resolve queries; assist in resolving medical coding discrepancies. Manage EDC, CRF to PDF CRF conversion process for generating regulatory submission ready CRF packages.

Qualifications and Experience:

A Bachelors or Master's degree in Health and/or Pharmaceutical Sciences, Physical/Biological or Chemistry fields.

Five years working as a Clinical Data Manager and at least 2 years managing teams of CDM's. Demonstrated an in-depth understanding of Clinical Trial Data Management concepts, processes and procedures, relevant issues related to or impacting Clinical Data Management, as well as Pharmaceutical Clinical Trial Regulations, Industry guidance, conventions and standards.

Demonstrated a strong  leadership in Clinical Data Management activities and a desire to excel in leading Data Management projects. Superior English communication skills are considered an asset!

Compensation: $120-$140K base, plus 10% bonus, Benefits and Pension.

Start date: ASAP

Please call Jason Edgar 416 225-2628 for all the details. Please send your CV directly to me for consideration: careers@jedgarcareers.com


MANAGER CLINICAL DATA STANDARDS TO $130K, GREATER TORONTO AREA

We are currently seeking a Clinical Data Standards compliance expert with the latest published electronic regulatory submissions standards for: CDISC - SDTM - ADaM and Define XML, Controlled Terminology (CT) published by the CDISC, the National Cancer Institute (NCI) and other clinical trial review bodies, eCTD's, Study Data Standards documents and any other relevant electronic submissions guidance issued by the USFDA, PMDA(as an example) and other global regulatory agencies.

The role of the Manager is to maintain a compliant library of metadata specification templates to ensure the efficient production of compliant regulatory submissions and databases. The Manager will lead the ongoing review of departmental processes to ensure that deliverables are produced following the most up to date compliance requirements and protocols. The Manager will also review and approve the draft of the SDTM and the ADaM prior to release of the specifications to clients prior to the production of the SDTM and ADaM databases. As Manager, you will be training teams on CDISC compliance updates and regulatory submission updates. This role will also help identify strong CDS team members within the Statistical Programming teams in order to develop them as SMEs. As a CDS expert, the Manager will participate in helping to ensure compliance and adherence to corporate governing documents when required.

You must have a Master degree in Statistics, Computer Science or a relevant field with 5-8 years of Clinical Research experience. You must be an expert in the most up to date and compliant Clinical Data Standards as mentioned: CDISC standards to specify, program and validate SDTM and ADaM compliant databases for numerous therapeutic areas. We are looking for someone with experience supporting eCTDs for individual studies and integrated safety and efficacy analyses. The incumbent must have in depth knowledge of clinical trial data management, statistical programming and analysis requirements for assembling and presenting trial results to regulatory agencies. Experience with multiple Regulatory agencies is preferred: FDA, Health Canada, MHRA, PMDA, ANVISA, EMEA etc.  This position requires an experienced personnel Manager and an effective communicator in order to work with experts at all levels of the organization and with client contacts.

Salary: $110 to $130K, Bonus: 10%, Start: 30 to 60 days, Location: Greater Toronto Area

Please call Jason Edgar 416 225-2628 for all the details. Please send your CV directly to me for consideration: careers@jedgarcareers.com


2 SENIOR DIRECTORS BIOSTATISTICS, CLINICAL RESEARCH,TO $240K PLUS BONUS, GTA OFFICE AND NEW JERSEY OFFICE

Our growing, successful quality focused Clinical Research client is seeking a Senior Director of Biostatistics to manage the daily activities of Biostatistics teams to ensure everyone is well-trained on SOP's and to promote efficiency, quality and timelines in all project deliverables.

Bring your technical expertise, positive personality and business savvy nature to the table and we have found you a match. Our client is looking for a dedicated communicator, senior leader who is ready for their next challenge. You will lead, guide, build and maintain key client relationships; be responsible for departmental growth and development, including budgeting, forecasting and proposal development. Mentoring and leading Biostatistics teams for all clinical phase 1-4 projects will be the main focus of this career opportunity.

Our clients specializes in several Therapeutic categories with a specialty in Oncology, Women's Health and CNS.

Qualifications: PhD or Master's degree in Statistics, Biostatistics or related. Minimum of 10 years of hands on experience in progressive roles, minimum 8 years of Study leadership experience in Biostatistics at a CRO or within a Pharmaceutical company preferred. Strong communication skills are essential to effectively operate in this fast paced environment. 

This high level position reports to a senior executive who reports into the President. Work in tandem with a strong team to reach new heights in Clinical Research and have the autonomy to act as a business owner with an entrepreneurial spirit.

Salary: $180-$250, 10% bonus  and full benefits package; GTA office based. 

Please call Cris Murray 416 225-6386, VP Recruitment, J. Edgar and Associates Inc. to apply to this exciting career opportunity. Please send your CV to me directly: jedgar@sympatico.ca in either a word or PDF format. Once you submit your CV, I will personally call you back to discuss and disclose our clients details so that you can determine your interest level.  

2 DIRECTORS STATISTICAL PROGRAMMING TO $ 230K PLUS BONUS, GTA, OFFICE BASED, NEW JERSEY USA, OFFICE BASED

Our client in Clinical Research is experiencing tremendous growth and as a result this newly created position has become available. We are searching for an experienced Statistical Programming leader to manage a team of like minded Quality driven professionals. This strategic opportunity will lead and manage a group of Statistical Programmers working on phase I-IV clinical trials in most Therapeutic categories.

Bring your technical expertise (Preparing SDTM data mapping specification, ADaM dataset specifications, data reviewer's guides and define .xml documents; perform QC review of documents; generate statistical tables, listings and graphs in accordance with Statistical Analysis plans and formats; ability to perform independent SAS programming validation of datasets; contribute to continuous improvement of clinical standards and SOP's; design and implement SAS macros) combined with your ability to instill a code of conduct to a group of highly educated Statistical Programmers promoting corporate culture and values is key to the success of this role.

Planning and organizing site specific events and activities and working with functional group leaders will be part of your mandate for this exciting high level career opportunity. Overseeing the day-to-day operational effectiveness of the office including liaising with all departments in order to achieve an environment of operational excellence, will be part of the management responsibilities.

Lead deliverable tasks in a timely, accurate and efficient manner to ensure quality and productivity leading study teams by participating in resource planning and managing timelines of project deliverables. Provide training, mentorship and technical guidance to the Statistical Programmers.

A Master's degree in Statistics, Biostatistics, Bioinformatics, Computer Science, Mathematics or other relevant field is required with at least 12 years of relevant industry experience using SAS in Clinical Trial analysis and reporting or a PhD degree or equivalent in statistical science, Mathematical analysis or related plus 10 years of relevant experience leading teams.

Bring your In-depth knowledge of clinical trial data processing and manipulation, hands on statistical programming and analysis and we can arrange for a meeting of the minds with our client!

Salary: $160-$210K, 10% bonus and a full and comprehensive benefits package.

Please call Jason Edgar 416 225-2628 for all the details. Please send your CV directly to me for consideration: careers@jedgarcareers.com

I will personally call you once you submit your CV to discuss and disclose our clients details so you can determine your interest level.


CLINICAL TRIAL MANAGER TO $85K, FULL BENEFITS AND 10%BONUS, OFFICE BASED, GTA 

JOB ACCOUNTABILITIES:

1.    Interact with personnel from study sponsors, investigational sites, vendors, and our client's functional groups to enable timely and high quality initiation and completion of clinical trials. This includes broader clinical trial and project management support across Clinical Operations, Biometrics, Safety, and Regulatory functional groups.

2.    Lead the site feasibility and selection process. Compile documentation for qualification of clinical sites. Support review of the documentation to ensure clinical sites comply with ICH-GCP and relevant local regulations.

3.    Assist with preparation and submission of regulatory documents to responsible authorities and IRB/ECs.

4.    Responsible for set-up and maintenance of studies in Clinical Trial Management System (CTMS) and Trial Master File (TMF), working with the Clinical Trial Assistant(s).

5.    Establish, maintain, and archive files of essential documents from investigative sites and for inclusion in Trial Master Files. These files must be maintained in a fashion so that they are continuously available for audit and completion for archive.

6.    Assist in review of documentation of information provided to study subjects, including informed consent forms.

7.    Assist in working with meeting planners and vendors to arrange for investigator meetings, off-site client or internal departmental meetings.

8.    Liaise across various clinical trial stakeholders to compile reports to track progress/status and clinical trial risks across all investigational sites.

9.    Contribute to the development of documents that facilitate or describe the management of the clinical trial. Examples of such documents include, study guides or manuals, and information collection tools.

10.   Responsible for the shipment and tracking of trial documents (site binders, manuals, guides, etc.)

11.   Record and inventory visit reports received from monitoring staff.

12.   Work with our client and vendor staff to maintain study portals, web sites, or newsletters.

13.   Assist with processing vendor invoices, investigator payments, and expense reports.

14.   Prompt study team staff to provide timely and accurate reports of travel expenses.

15.   Participate in the development and maintenance of, and adhere to departmental SOPs and guidelines.

16.   Support business development efforts directly by supporting task-based activities during RFPs and bid cycles, and indirectly by building trust-based relationships with clients through performance, reliability, and strong customer service. 

17.   Prepare, maintain, and complete training on study-specific and (or) applicable sponsor SOPs.

18.   Support sites in their efforts to prepare for audits conducted either by sponsors or regulatory authorities.

19.   Plan and carry out professional development.

20.   Provide support in Clinical Operations, Project Management, or other functional areas as required.

Please call Cris Murray 416 225-6386, J. Edgar and Associates Inc. to find out more details. Please send resume to me directly: jedgar@sympatico.ca


SENIOR CLINICAL RESEARCH ASSOCIATE TO $130K US, Plus 401K, CAR ALLOWANCE, FULL BENEFITS. 70% Travel, Work from Home...based anywhere in Southeast USA.

Our client, specializing in Clinical operations is searching for a Senior Clinical Research Associate where you will be responsible for monitoring, reporting, tracking study progress, and assessing compliance of the conduct of clinical trials with regulatory requirements, the clinical study protocol, study-specific plans, and Standard Operating Procedures. 

The role includes leadership of the Clinical Operations study team as well as assessment and direction of other Clinical Operations staff assigned to studies.  We are looking for an interactive team player who knows how to work with study sponsors, investigational sites and vendors to enable timely and high quality initiations and completions of Clinical Trials. Our client needs your ability to identify, evaluate and qualify investigators and investigational sites for participation in clinical trials.

Your ability to compile documentation for qualification of clinical sites and ensure they are compliant with ICH-GCP and relevant local regulatory bodies will enable your success in this newly created role.

Bring your keen sense of contract negotiations to collectively participate in and prepare presentations for clinical trials initiation meetings and or training sessions.  Perform on-site monitoring of clinical studies and document monitoring activities through submission of monitoring reports to Clinical Operations management for review.  Responsible for site management.

Requirements: Bachelors degree in Life Sciences or Health related field.  Minimum of 4-5 years of experience in monitoring clinical trials in the field required.  Excellent written and oral presentation skills, thorough knowledge of GCP's and ability to travel to local study sites up to 70%.

Salary: $95-$135K.

Bonus: 401K, car allowance and other relevant expenses plus full health benefits package, Perks and 4 weeks paid vacation.

Please call Cris Murray 416 225-6386 at J. Edgar and Associates Inc. to find out more information about this exciting new opportunity.

Please call Jason Edgar 416 225-2628 for all the details. Please send your CV directly to me for consideration: careers@jedgarcareers.com


CLINICAL PROJECT MANAGER TO $85K PLUS 10% BONUS, GTA OFFICE BASED

We are seeking a Clinical Project Manager to drive continued success in this exciting clinical research field as we are seeking committed, skilled, and customer-focused individuals to join our clients winning team as a Clinical Project Manager (focused on Biometric Project Management) for our Toronto/Markham, Ontario, Canada location.

Key Responsibilities:

The incumbent is responsible for defining project scopes and estimating budgets, planning, directing, controlling project activities, managing resources and budgets, as well as project team performance of cross-functional teams engaged in clinical research and development activities. This position is also accountable for reporting of project progress status to our clients internal management and its clients. These activities may include but are not limited to managing projects with activities focused on clinical operations, data management, statistics, medical writing, subject randomization and drug supply management (IWRS), administration of data monitoring and adjudication committees, as well as preparing drug submissions to regulatory agencies.

When required, the incumbent may assist the organization in responding to and preparing for Request for Information and Request for Proposals, and subsequently defining work scopes and budgets, and performing contract administration activities.

When required, the incumbent may perform clinical trial planning, management, and site monitoring from the initiation of a trial to its closure.

  1. Manage projects with activities focused on one or more of the following: clinical operations, data management, statistics, medical writing, subject randomization and drug supply management (IWRS), administration of data monitoring and adjudication committees, as well as preparing drug submissions to regulatory agencies.
  2. Integrate information to define work scopes and estimate budgets, develop and manage cross-functional project work plans including resource requirements and utilization, budgets, quality deliverables and timelines.
  3. Manage all project management aspects of assigned Phase I -IV clinical trials and in accordance to ICH guidelines, FDA, Health Canada, EMA, and other applicable regulatory and legal requirements.
  4. Be the primary point-of-contact for clinical trial sponsors to ensure the timely initiation and completion of clinical projects.
  5. Lead cross-functional project teams. Manage the planning, implementation, conduct and reporting of assigned projects within the established timelines and budgets, and with the quality and requirements necessary for regulatory approvals.
  6. Coordinate activities between our client and trial sponsors, and with various supporting groups or third party vendors (e.g., central lab and other specialty labs) to ensure that all contractual obligations are met.
  7. Proactively track and manage the financial status against budget and reconcile expenses across sub-streams of activities.
  8. Proactively track and manage project tasks against timelines and hours spent/budgets, alert management when there are risks of having major deviations.
  9. Prepare project status reports and maintain accurate and current details. Present project status to internal and external stakeholders.
  10. Function as meeting facilitator for the meetings involving various internal and external participants.
  11. Function as facilitator of problem solving and conflict resolution.
  12. Communicate project action items and key decisions through timely minutes and follow up actions.
  13. Conduct “lessons learned” meetings with project team members to learn from failures and prevent same from future projects.
  14. Contribute and/or participate in the performance evaluation of staff who performed under the responsible projects.
  15. When required, the incumbent may assist the organization in responding to and preparing for Request for Information and Request for Proposals, and subsequently defining work scopes and budgets, and performing contract administration activities. Attend and present at bid defense meetings.
  16. When required, perform clinical trial planning, management, and site monitoring from the initiation of a trial to its closure.
  17. May provide support in Clinical Operations as required, such as the following:
    - Assist in the development of study-specific training materials.
    - Manage the process of setting up and maintaining the Trial Master File.
    - Review/compile documentation for qualification of clinical sites. Support review of that documentation to ensure that those clinical sites comply with ICH-GCP and relevant local regulations.
    - Assist with the preparation and negotiation of contracts with vendors and investigational sites.

Qualifications and Experience:

  1. B.Sc. or M.Sc. in life sciences or health related field.
  2. Minimum of 8 years’ clinical research experience within a pharmaceutical, biotechnology, or CRO setting.
  3. Experienced as a clinical trial monitor, initiating, monitoring, and closing out clinical trials will be desirable for Clinical Operations support tasks.
  4. Ability to travel a maximum of 30% of working hours may be required.
  5. Demonstrated understanding of cross-functional processes including clinical operations, statistics, data management, subject randomization and drug supply management, data monitoring and adjudication committees, regulatory affairs, and medical writing.
  6. Knowledge and understanding of ICH guidelines, FDA, Health Canada, and EMA regulations.
  7. Ability to define scopes and estimate budgets, plan and manage projects, including resource requirements and utilization, hours spent vs. budgets, key deliverables and timelines.
  8. Demonstrated leadership abilities, including setting goals for others and driving to achieve them in accordance with allocated resources, timelines, and budgets.
  9. Excellent interpersonal, oral and written communication skills. Demonstrated strong negotiation and presentation skills.
  10. Strong ability in problem-solving including conflict resolution.
  11. Fluency in French, including medical and scientific terminology, will be desirable.

Salary: $80-$85K plus 10% bonus, vacation and comprehensive Health care benefits.

Please call Cris Murray at 416 225-6386 to find out more details. Email resume in Word format to: jedgar@sympatico.ca


SENIOR IN-HOUSE CLINICAL RESEARCH ASSOCIATE TO $130K, PLUS 10% bonus, FULL BENEFITS, 4 Weeks vacation, RRSP matching contribution, GTA

Our client, specializing in Clinical operations is searching for a Senior Clinical Research Associate where you will be responsible for monitoring, reporting, tracking study progress, and assessing compliance of the conduct of clinical trials with regulatory requirements, the clinical study protocol, study-specific plans, and Standard Operating Procedures. 

The role includes leadership of the Clinical Operations study team as well as assessment and direction of other Clinical Operations staff assigned to studies.  We are looking for an interactive team player who knows how to work with study sponsors, investigational sites and vendors to enable timely and high quality initiations and completions of Clinical Trials. Our client needs your ability to identify, evaluate and qualify investigators and investigational sites for participation in clinical trials.

Your ability to compile documentation for qualification of clinical sites and ensure they are compliant with ICH-GCP and relevant local regulatory bodies will enable your success in this newly created role.

Bring your keen sense of contract negotiations to collectively participate in and prepare presentations for clinical trials initiation meetings and or training sessions.  Perform on-site monitoring of clinical studies and document monitoring activities through submission of monitoring reports to Clinical Operations management for review.  Responsible for site management.

Requirements: Bachelors degree in Life Sciences or Health related field.  Minimum of 5 years of experience in monitoring clinical trials in the field required.  Excellent written and oral presentation skills, thorough knowledge of GCP's.

Salary: $100-$115K.

Bonus: 10% annual bonus, relevant expenses plus full health benefits package, RRSP matching, a monthly Fitness expense and 4 weeks paid vacation.

Please call Cris Murray 416 225-6386 at J. Edgar and Associates Inc. to find out more information about this exciting new opportunity.

Please email your CV in a word format to me directly: jedgar@sympatico.ca


  2 CLINICAL DATA MANAGERS, INTERMEDIATE AND SENIOR TO $95K PLUS 10% BONUS, GTA or Work From Home if you live outside Toronto

We are seeking 2 CDM's  in total.  The Clinical Data Manager's will lead assigned data management projects by applying project management skills and data management techniques to ensure timely and quality deliverables. The incumbents will manage project timelines and coordinate activities for assigned projects, and be responsible for the development of Data Management Plans, clinical trial case report forms, databases, and overseeing data processing.

A bachelors' degree in health science, registered nurse, or higher equivalent education in relevant disciplines, with a minimum of 2-5 years experience in clinical trial data management, and demonstrated leadership ability to effectively manage clinical trial data management activities and integrate them with the entire clinical trial operations; must communicate effectively, orally and in writing. Experience with clinical trial electronic data capture systems and in particular must have experience using MediData Rave. Solid understanding of clinical drug development process and knowledge of FDA regulatory requirements and ICH/GCP guidelines is required. In addition, the incumbent must have excellent oral and written communication skills and to apply such skills in logical and algebraic operations.
 
To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our clients winning team as a Clinical Data Manager.

key accountabilities are:  Plan, manage, control and performs data processing and management activities for assigned projects.  These tasks are performed in a timely and accurate manner and in compliance with trial sponsors’ requirements.   Lead assigned data processing and management projects by applying project management skills, data processing and management techniques. Manages timelines and coordinates activities for assigned projects.  Specify database validation checks for assigned studies.  Lead efforts in developing and maintaining standard database validation checks for common modules as well as for therapeutic/drug area specific modules.  Define and monitor clinical trial dataflow and quality control processes in accordance to corporate SOPs, Good Working Practices, and unit guidelines. Perform clinical trial site monitors’ training on dataflow and quality control processes.  Design and review patient Case Report Forms and database schema.  Test data capture/entry screens.  Accurately and efficiently validate electronically captured data.  Write clear queries on missing data and data points failing pre-defined range checks and/or logical checks.  Lead efforts in building a standard query library for common database modules as well as for therapeutic/drug area specific modules.  Perform quality control procedures on assigned database during the trial, and additional database closure checks at the end of the study.  Train and supervise Data Entry personnel and junior data management personnel on study procedures, study specific handling and management of trial data.  Validate and distribute study progress status reports to internal and external study team members.  Assist in resolving data coding discrepancies resulting from the coding of medical events, treatment procedures and medications.  Maintain and prepare for final archival of data management documentation relevant to the assigned clinical trials, and assist the corporate archivist in assembling and archiving clinical trial data and study documentation.   Cooperate with and assist, when required, data management quality assurance (QA) personnel in performing QA procedures on trial Case Report Forms (CRFs), database schema and databases for assigned studies.

Salary - $70-$95K plus bonus and full health benefits. Start: ASAP.

Please call Cris Murray 416 225-6386 for all the details.

Please call Jason Edgar 416 225-2628 for all the details. Please send your CV directly to me for consideration: careers@jedgarcareers.com


PRINCIPAL BIOSTATISTICIAN  WITH MSc. OR Ph.D. TO $150K, TORONTO, OR WFH OUTSIDE OF TORONTO PLUS 10% BONUS

Our client has opened a third international location in Shanghai and we are searching for several senior talented Biostatisticians who will be accountable for developing, applying and/or providing expertise in clinical trial statistical and programming methods and techniques to effectively manage and complete statistical and programming projects, and to support the company’s mission, strategies, customers and priorities. In addition to the technical accountabilities, this position assumes project management responsibilities in directing and managing statistical and programming team activities for clinical trials from the development of study protocols to the completion of study reports. May represent division and the company, participate in business development and customer relationship management activities, and provide leadership in executing divisional and corporate plans.

  1. Provide leadership/expertise in day to day statistical and programming team operations and in resolving complex problems for assigned projects, or as a consultant to others. 
  2. May represent division or company - provide leadership in major divisional/corporate efforts and in executing divisional or corporate plans. These efforts may include, but not limited to, the following:
    - Providing leadership/expertise in research and development of statistical methodologies.
    -  Investigating and implementing new technologies, processes and procedures.
    - Developing and executing customer relationship management plans.
    - Participating in new business development and bidding processes.
  3. Act as Lead Biostatistician/Teammate Biostatistician to interact with clinical trial sponsor companies, and oversee projects for a sponsor company and/or for given therapeutic areas.
  4. Lead assigned projects by applying project management skills, statistical and programming techniques to deliver quality and timely deliverables.
  5. Plan, develop and monitor timelines for statistical and programming activities in accordance with medical/clinical activities for assigned projects. Jointly with immediate management, assess statistical and programming resource needs and manage the assigned resources to the projects.
  6. Write Statistical Analysis Plans (SAPs) for assigned projects. Perform review on the SAPs written by others.
  7. Provide statistical input into the development of study concept, protocol synopsis, protocol, and protocol amendments.
  8. Perform review of clinical trial documents, including but not limited to the following: study concept sheet, protocol synopsis, protocols and amendments, statistical and programming documents generated by others, and clinical study reports or publications. 
  9. Develop or perform review of statistical programming technical specifications, which include but not limited to the following: clinical trial data handling rules, statistical derivations/algorithms, SDTM and ADaM dataset specifications, and statistical testing/modeling approaches.
  10. Perform quality control (QC) activities on statistical datasets such as SDTM and ADaM datasets. These activities include but not limited to the following: perform independent statistical programming to validate the datasets, perform QC review of the datasets, assess and recommend resolutions on discrepancies between the datasets generated by two Statistical Programmers or Biostatisticians.
  11. Perform quality control (QC) activities on statistical analysis results or data displays such as statistical summary tables, listings, and graphs (TLGs). These activities include but not limited to the following: perform independent statistical programming to validate the TLGs, perform QC review of the TLGs, assess and recommend resolutions on discrepancies between the results generated by two Statistical Programmers or Biostatisticians.
  12. Generate or perform QC on clinical trial patient randomization codes and treatment assignments. Oversee IxRS (IVRS and IWRS) implementation of patient randomization codes and treatment assignments for assigned projects.
  13. Provide statistical and programming input into clinical trial Case Report Forms (CRF) design for assigned projects, and may provide input to the database design data flow, variable naming conventions and data structure, etc. when required.
  14. Participate in clinical trial kick off meeting, investigators meeting, and ongoing trial management team meetings as per project requirements.
  15. Write statistical and results sections of the Clinical Study Report, or perform QC review of the CSR.
  16. Provide statistical and programming support to clinical trial results dissemination activities, such as generation of data reports for abstracts, manuscripts, posters, and presentations, etc.
  17. With assistance from the Archivist, archive study documentation upon the completion of final Study Reports.
  18. Participate and contribute to the training, mentoring, and development of new Biostatisticians or Statistical Programmers.
  19. Adhere to company governing documents (policies, SOPs, work instructions, templates and checklists), may contribute to the further development of these documents.
  20. Contribute to organization development and growth by participating in the interview and evaluation process for job applicants.
  21. Plan and carry out professional development.  

Qualifications and Experience:

A Ph.D. degree or equivalent in statistical science, mathematical analysis or related plus 7 years of relevant experience or a Master’s degree plus 10 years relevant experience with demonstrated ability and sustained performance at the Ph.D. level.

If you are interested in confidentially exploring this opportunity, kindly send your resume to me directly at:  jedgar@sympatico.ca, 416 225-6386

 


 PRINCIPAL OR SENIOR BIOSTATISTICIAN WITH MSc. OR Ph.D. TO $170K, NEW JERSEY OR TELECOMMUTE WFH

Five years experience in clinical drug trials (Phase I to Phase IV) or 5 years developing SAS datasets (R is an asset) is required along with the ability to meet with a variety of stakeholders to assess and understand their statistical needs. Above all, an ability to communicate complex details in a concise manner is required.

Your responsibilities include: protocol development, clinical study design, writing ICH reports, medical writing, manuscript preparation, development of statistical analysis plans, consulting in bio-statistics, study design, regulatory issues, interviewing and selecting new biostatisticians as well as SAS programmers and reviewing SOP’s

Educational and Experience:
Ph.D. or MSc. with significant experience in Statistics/Biostatistics
5 years experience in clinical drug development in a pharma/biotech, CRO or academic environment
Protocol and Clinical Study design
Clinical data management
SAS programming R programming, Matlab, LaTex
Clinical research report writing
Exposure to many therapeutic areas including Cardiovascular, Oncology, Endocrinology, CNS, Women's and Men's Health, ID etc...
Experience in the analysis and reporting of Phase I-IV clinical trials
Advanced communication skills written and oral
Excellent interpersonal skills
Flexible and comfortable with tight and changing timelines
Knowledgeable with ICH, FDA, EMEA and TPD guidelines and regulatory issues

Salary - $155-$170K, 3 week vacation, New Jersey or telecommute

Please call Jason Edgar 416 225-2628 for all the details. Please send your CV directly to me for consideration: careers@jedgarcareers.com


SENIOR MANAGER MEDICAL WRITING, CLINICAL RESEARCH AND REGULATORY, TO $150K, GTA

We are currently seeking a Leader for a Medical Writing team in a highly successful Research environment. The Senior Manager/Director will work to advance the strategy and creation of high-quality documents to support efficient and successful regulatory submissions for Canadian and US Regulatory bodies, following established internal SOPs and GCP Compliance in accordance with the FDA, Health Canada, ICH and EMEA. This role will plan and manage oversight for medical writing deliverables for a wide variety of large complex clinical/regulatory submissions 40% of the time with 60% of time (roughly) dedicated to hands on Medical Writing.


Management Oversight deliverables:  Documents such as CSRs of all phases(mostly Ph II-IV) and IBs according to regulatory requirements and internal document standards. this includes but is not limited to CTD summaries, PIPs, or regulatory responses. This requires Technical bench strengths in order to lead team strategy and writing deliverables. This position will manage Document timeline and resource planning in order to achieve high quality and compliant deliverables. High standards for optimal presentation of data for achievement of document objectives are required. This position will work collaboratively with functional contributors in Clinical Research, Biometrics, and Medical Affairs Therapeutic category Leadership, ensuring all source information and data are appropriately reported in terms of accuracy, completeness and scientific interpretation, and in accordance with project timelines. The Medical Writing Sr. Mngr/Director will manage the coordination and compilation of final documents and appendices that are provided by other functional teams.  As Director, you will contribute to development work in relation to document standards, continuing template development, and other aspects of document management utilizing your proven experience and success in delivering compliant Medical and Clinical documents. This position works with and reports to Executive Management and the company President in a 9-5 based office environment in the GTA.

Education and Requirements: BA, BSc, Master degree or PhD is required with demonstrated success particularly at the individual study report level with excellent verbal communication skills who can effectively communicate with a variety of teams and individuals. Strong experience with Regulatory compliance and standards and 7-10 experience leading document creation with Team management experience. You must have well developed computer skills including proficiency in Word, Adobe, Excel, and a compliant Regulatory Document Management System.  

Salary - $120-150K, Bonus - 10%, Complete and Thorough Benefits Plan plus Company Incentives. 

Call Jason Edgar for all the details at 416 225-2628, Resumes: careers@jedgarcareers.com 


SENIOR PHARMACOKENETIC SCIENTIST, TO $150K PLUS BONUS, GTA

Perform pharmacokinetic and pharmacodynamic (PK/PD) data analysis, modeling, and reporting to support clinical trial designs, compound development plans, and regulatory submissions for the Statistical Science Unit

 ACCOUNTABILITIES: 

 1.       Write clinical trial Statistical Analysis Plans including PK/PD analysis components or write separate PK/PD Analysis Plans.

2.       Perform PK parameter estimation, conduct PK/PD data analysis including advanced population PK/PD modeling and simulation and/or disease modeling using software such as WinNonlin, NONMEM, S-PLUS, Clinical Trial Simulator, etc.

3.       Generate predictive simulations and provide input into trial protocol development.

4.       Author and/or review PK/PD related documents or reports such as PK Study Reports.

5.       Contribute to the clinical pharmacology sections of relevant documents, such as clinical study protocols, clinical study reports, investigator's brochures, briefing documents, and IND/NDA submissions.

6.       Work closely with regulatory affairs personnel to provide PK/PD data in support of regulatory communications and presentations as needed.

7.       Represent the company on PK/PD issues at appropriate scientific meetings, for regulatory issues, and with clinical trial clients.

8.       Play an active role on cross-functional project teams as a clinical pharmacology representative.

9.       Lead assigned projects by applying project management skills, to facilitate better decision making, improve business operations and discover, improve, develop or defend new or existing products.

10.   Participate in evaluating the performance of assigned project personnel.

11.   Follow up on the development and implementation of new pharmacokinetic and pharmacodynamic methodologies which will improve current/future decision making or divisional/corporate business processes, and related regulatory requirements and practices.

12.   Participate in the development and maintenance of, and adhere to divisional SOPs and guidelines.

13.   Participate in the development and maintenance of, and adhere to therapeutic area specific standards and conventions.

14.   Participate in the development and maintenance of, and adhere to corporate policies and SOPs. 

15.   Plan and carry out professional development. 

KEY EQUIPMENT/SOFTWARE USED:

Microsoft Word, PowerPoint, Excel, Outlook, Relational database concept, SAS and sample size calculation software and WinNonLin or other relevant pharmacokinetic software.

REQUIREMENTS:  

 1.       Ph.D. in Pharmacokinetics, Pharmacodynamics, Biopharmaceuticals, Pharmacology or related field with 5 years of related experience, or M.Sc. with 7 years related experience.

  2.       In-depth knowledge of clinical development, clinical pharmacology, and PK/PD is required.

3.       Proficient in using WinNonlin, or other relevant pharmacokinetic software for PK/PD analysis and modeling.

4.       Familiarity with SAS if preferred (or willing to learn and master SAS skills).

5.       Good communication and interpersonal skills.

6.       Skilled in scientific writing and data interpretation.

7.       Demonstrated ability for logical thinking, vision, and creativity necessary to function effectively with little structure or supervision.

8.       Ability to multi-task, managing multiple projects with competing and aggressive timelines.

 Call Jason Edgar at 416 225-2628 for all the details. Resumes: careers@jedgarcareers.comto:


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