Definition: Works under general supervision of the Clinical Operations hierarchy as required performing tasks in the conduct of clinical trials. Under general direction and guidance from the Project Manager participates with the design and execution of clinical trials and research projects.

Essential Functions:  The following duties represent the principle job duties however they are not all inclusive:

• Participates in the clinical trial process from initiation to closing as required
• Ensures adherence to implemented Quality Assurance processes
• Participates in the development of quality control processes
• Participates in the development of the study related documents
• Issues progress reports on the clinical trial activities
• Assists in the preparation of ethics submissions
• Prepares and submits documents to regulatory agencies
• Participates in the preparation of the Investigator’s meeting
• Coordinates central and local laboratory activities
• Prepares reports for physician and patient payments
• Prepares recruitment update reports for the Sponsor
• Participates in department and project audits
• Conducts safety review and reports Serious Adverse Events (SAE)
• Participates in the development / review process of standard operating procedures (SOP)
• Organizes workflow in compliance with timelines
• May be called upon to do data entry tasks when required

Skills and Qualifications:

Knowledge of:

• MS Office
• Electronic systems currently in use at JSS Medical Research to process data for clinical trials
• Medical Terminology
• Requirements of Good Clinical Practices
• Requirements of Good Documentation Practices
• Requirements of FDA 21 CFR Part 11 for Handling of Electronic Records

Ability to:  

• Maintain and exhibit discretion at all times when handling confidential information
• Research and verify information to ensure accuracy
• Enter accurate data as instructed
• Communicate effectively orally and in writing
• Assume multiple and concurrent tasks and responsibilities
• Establish and maintain cooperative and effective working relations with fellow employees
• Demonstrate integrity, respect, professionalism, commitment and accountability

Definition: Under the direction of the Associate Director of Clinical Operations and the input of the Project Manager as required, leads the project team and is responsible for coordinating project timelines and objectives related to the clinical study. Assures the management of clinical trial from initiation to closing performing project management tasks, providing support, resolving problems and organizing the team and associated tasks to meet study timelines.

Successful candidate must have previous project managment experience in a CRO.

Essential Functions:  The following duties represent the principle job duties however they are not all inclusive:

• Ensures adherence to QA processes
• Participates in the quality control processes
• Monitors and directs the project team, suppliers, and client compliance with contract terms and commitments
• Prepares and communicates the project work plan to the project team, including project scope, schedule and budget
• Provides work assignments to project team members, and monitors/manages project production for compliance with schedules, budget and quality objectives
• Monitors suppliers’ progress and performance, and reviews suppliers’ invoices
• Maintains and monitors project financial information and manages project costs within budget constraints
• Schedules and coordinates project meetings with the project team, regulatory agencies, the client, and others involved with the projects
• Participates in the revision of the study protocol
• Creates / reviews Finalize study related documents
• Issues progress reports on the clinical trial activities
• Participates in the site recruitment and training of Sites
• Prepares / submits Ethic Committee packages
• Prepares / submits documents to Regulatory Agencies
• Plans / prepares / presents at Investigators’ meeting
• Requests preparation of study software and provides relevant details to IT
• Requests the development of the Randomization Schedule from data analysis
• Requests the completion of data analysis as per study and client requirements
• Coordinates central and local laboratory processes
• Prepares reports for Physician / Patient Payments
• Prepares recruitment update reports to the Sponsor
• Oversees the data clarifications process
• Maintains contact with sponsor and site representatives
• Conducts safety review and report Serious Adverse Events (SAEs)
• Assists in the preparation of data analysis
• Assists in preparation of interim and final reports
• Assists in the writing/reviewing of manuscripts
• Prepares/reviews abstracts, posters, presentations, CD-ROMs, etc
• Participates in the development and review process of SOPs

Skills and Qualifications:

Knowledge of:

• The CRO & Life Sciences industries (required)
• Project management principles (must)
• Quality assurance principles
• MS Office
• Electronic systems currently used at JSS Medical Research
• Good Clinical Practices
• Good Documentation Practices
• 21 CFR Part 11 for Handling of Electronic Records

Ability to:  

• Maintain and exhibit discretion at all times when handling confidential information
• Lead a multi-disciplinary project team
• Make independent decisions and use good judgment
• Plan, organize, and prioritize tasks efficiently
• Communicate effectively orally and in writing
• Assume multiple and concurrent tasks and responsibilitiesv
• Establish and maintain cooperative and effective working relations with fellow colleagues
• Communicate effectively with clients and site representatives
• Demonstrate integrity, respect, professionalism, commitment, accountability

Experience and Education:  

• M.Sc. in Life Sciences or equivalent B.Sc. with relevant work experience in clinical research
• 2 years’ experience as a Project Manager in a CRO (must)
• Experience managing international studies (asset)

Reports To: COO

Department/Business Unit: Clinical Operations

Please apply only if you have Relevant experience in CRO with extensive monitoring background.

Definition: The Manager of Clinical Research Associates (CRAs) will manage a group of Clinical Research Associates and will coordinate their monitoring activities. She/he will assist the COO in overseeing the general management of the Clinical Operations department’s staff and services. Contributes to the ongoing improvement of the overall efficiency of the Clinical Operations department including interdepartmental relation. Collaborates cross-functionally with the Director, Clinical Operations to ensure client’s satisfaction.

Essential Functions:  The following duties represent the principle job duties however they are not all inclusive:

• Assists with developing and executing the departmental objectives
• Collaborates with Business Development department in developing Service Agreement proposals and participates in bid defense presentations
• Tracks CRA staff resource utilization, assists with allocation of clinical study/project to appropriate staff and ensures adequate staff support of each clinical study/project
• Attends Internal and Sponsor Kick-Off meetings
• Assures that clinical studies/projects are conducted in compliance with Service Agreement (including deliverables and timelines), and applicable regulations and Standard Operating Procedures
• Provides leadership to the CRA team, co-monitoring and site monitoring concurrently
• Oversees planning, preparation and presentations at Investigator’s Meeting
• Participates in the quality control processes.
• Approves Project Plans, Monitoring Plans, CRA Quality Oversight Plans, Site Releases, IT Requests, Purchase Orders, and Vacation Requests.
• Provides support and direction to project team members, helps with problem resolution, and provides assistance and guidance to the Clinical Research Associates.
• Liaises with sponsor and site representatives, as required to ensure customer satisfaction
• Ensures that clinical studies/projects status, change orders and team members’ time are tracked using the Project Management software
• Liaise with other departments to ensure timely deliverables, as required
• Contributes to the development of department and interdepartmental Standard Operating Procedures
• Analyzes and recommends improvements to current systems and processes to ensure consistency and increase efficiency in the conduct of clinical studies/projects
• Develops and/or implements tools to improve efficiency in the conduct of clinical studies/projects
• Builds talent and capabilities of staff through proactive coaching, mentoring and development opportunities
• Coordinates and supervises staff providing constructive feedback
• May also assure the management and lead the project team for one or more concurrent clinical studies/projects from initiation to closing.

Skills and Qualifications:

Knowledge of:

• CRO and Life Science Industries is mandatory.
• Project management principles
• Quality assurance principles
• Business planning and financial budgeting
• MS Office
• ICH Guidelines
• Good Clinical Practices
• Good Documentation Practices
• FDA 21 CFR Part 11 for handling of electronic records requirements

Ability to:  

• Maintain and exhibit discretion at all times when handling confidential information
• Lead a multi-disciplinary project team
• Make independent decisions and use good judgment
• Plan, organize, and prioritize tasks efficiently
• Communicate effectively orally and in writing
• Assume multiple and concurrent tasks and responsibilities
• Establish and maintain cooperative and effective working relations with fellow colleagues and employees
• Communicate effectively with client, site and supplier representatives
• Demonstrate integrity, respect, professionalism, commitment, accountability

Experience and Education:  

• M.Sc. in Life Sciences or equivalent B.Sc. with relevant work experience in clinical research
• Relevant experience in CRO with extensive monitoring background is a must.
• Bilingual is a must