The TMF Specialist contributes to the success of the TMF business process and supports study teams as a contributing member in the role of TMF Specialist. The TMF Specialist is responsible for supporting process and system development to support and maintain high quality and compliant Trial Master Files (TMFs). The TMF Specialist provides expertise and guidance across study teams, functions and vendor partners. The TMF Specialist reviews and approves or identifies issues with TMF content using a specific workflow and following relevant guidance. This position will participate as a study team member and will collaborate with functional SMEs to address consistent quality gaps. This position will also mentor In-House CRAs and Research Associates as well as provide oversight on milestones as they relate to TMF management. The TMF Specialist must be familiar with “second review” and authorization for site approval/IP Release.