Senior Clinical Trial Manager ~ Contract Position

Job Responsibilities

• Accountable for all operational aspects of assigned clinical trial(s) or geographical region.
• Responsible for selection of vendors/CROs and provide effective ongoing management and oversight to vendors/CROs to ensure compliance and execution of deliverables within the approved budget, study timeline, and study protocol.
• Works closely with investigative site personnel, CROs, and other study vendors.
• Maintain and track clinical trial progress and provide status update to stakeholders.
• Manage study contracting, budget, forecasting, accruals and payment process for all clinical trial vendors including investigational sites.
• Collaborate with Data Management to ensure correct CRFs content is collected, prepare/implement CRF completion guidelines, and coordinate delivery of data updates, listings and study reports.
• Drafts and coordinates review of relevant documents including protocols, informed consents, case report forms, monitoring plans, investigator brochures and clinical study reports.
• Proactively identifies potential issues/risks and recommends/implements solutions.
• Provides leadership to the clinical operations team working on the assigned program.

Experience and Skills

• B.S./ B.A. in biological sciences, advanced degree preferred with 5-10 years of relevant industry experience.
• Ability to travel as required for the program (10-15%).
• Demonstrated knowledge of FDA, ICH and GCP regulations and guidelines.
• Experience in leading teams, including CROs, consultants and vendors.
• Strong analytical and problem-solving skills at a project level and collaborate with colleagues to generate solutions.
• Strong communication and influence skills and ability to create a clear sense of direction.
• Ability to deal with time demands, incomplete information or unexpected events.
• Outstanding organizational skills with the ability to work independently, multi-task and prioritize.
• Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities.