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 responsibilities
• 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)