$146,000–$161,000/yr
- Act as a central contact for Clinical Study Teams for TMF management and participate in the development of quality oversight processes for TMF management of clinical trials.
- Review and approve TMF documents, co-author and manage TMF documents such as TMF Plan and Index, and ensure quality management by reporting metrics and reconciling outstanding queries.
- Oversee the activities of external vendors, ensuring study documents are adherent with ICH-GCP guidelines and regulatory requirements and that assigned studies are inspection-ready.