Clinical Trial Manager

Job description

Position Summary: The Clinical Trial Manager is responsible for managing the execution of clinical studies and data collection. The incumbent oversees the review, monitoring and adherence to clinical protocols, as well as fulfilling activities related to study completion. The Clinical Trial Manager will interact internally and externally with members of the cross-functional study team. Essential Job Functions and Responsibilities: These may include but are not limited to: - Provide oversight of clinical research studies across all functional areas of the drug development process. - Provide operational and strategic input into study documents such as synopsis, protocol, ICF, CRFs, CRF Completion Guidelines, Study Execution Plans, Clinical Data Review Plan, Clinical Database edit specifications, Clinical Study Report (CSR) development, etc. - Develop the subject recruitment/retention strategy and related initiatives. - Oversight of TMF set-up, ongoing quality review, and final reconciliation of study documents including review of site regulatory documents/packages and obtaining of appropriate site insurance, and/or supervision of team members performing these activities. - Developmen...