Senior Clinical Trial Manager (Contract)

Job description

Job Description: POSITION SUMMARY The Senior Clinical Trial Manager (Contract role) will be responsible for overseeing all operational phases of clinical research, from start-up to database lock, ensuring studies are completed on time, within budget and in compliance with ICH-GCP guidelines and regulations. RESPONSIBILITIES: This position is responsible for, but not limited to, the following: - Lead all clinical site interactions (including assistance with IRB/EC applications, contract negotiations, enrollment tracking, clinical trial material and clinical supply requests, issue resolution, etc.) - Own and manage all trial start-up, conduct, and close-out activities according to industry and corporate standards - Lend expertise to the preparation of key clinical documents in conjunction with other team members (e.g. protocols, informed consent, amendments, CRF’s, training materials, project plans, monitoring plans, data plans, statistical analysis plans, summary reports, annual reports, etc.) - Establish professional rapport and engage in frequent communication with investigational site personnel in order to keep study on-track - Track internal metrics, timelines and budgets - Comm...