The TMF Specialist is responsible for overseeing the overall management and quality of essential clinical trial documents to ensure compliance with applicable regulatory and local requirements. This position will provide management and oversight of Trial Master File (TMF) filing activities to ensure audit and inspection readiness for clinical trials. Responsibilities include working with multi-functional study teams and vendors to ensure the maintenance of TMFs, both electronic and paper, in a state of inspection readiness. The specialist maintains study-specific TMF Management Plan, performs QC on TMF documents to ensure high quality per data quality standards and specified system guidelines, manages conduct of TMF quality reviews by cross-functional study team, and drives to closure quality review findings. They support the functional owners in the identification and management of the collection of study specific TMF content, (both sponsor and CRO). The specialist assesses outstanding issues and follows through to resolution, and has daily interaction with the Clinical team, clinical project managers, and members of the cross-functional study team. They plan, execute, and lead study-specific meetings, follow international good clinical practice guidelines/regulations and standard operating procedures for executing clinical studies, and support other trial-related operational activities as needed and assigned.
TMF Specialist • Savannah, GA, United States
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