TMF Lead / Senior TMF Lead

Job Overview

The TMF Lead/Senior TMF Lead is responsible for overseeing, creating, managing, and delivering the eTMF in compliance with Good Clinical Practice (GCP), E6 ICH Guidelines, and other regulatory documents, including 21 CFR Parts 312 and 314, EMA Clinical Trials Directives, and Precision Standard Operating Procedures (SOPs). The Senior TMF Lead handles complex and challenging studies and supports the development and implementation of TMF-related processes and systems.

Essential Functions

• Creates and executes the study TMF Plan and project TMF Document Index, ensuring the entire study team understands expectations and manages communication of any changes in the TMF.
• Attends and contributes to project kick-off meetings, internal/external meetings, and ad hoc meetings to ensure the project team is aware of the status of the eTMF, gaps, and escalations.
• Ensures the eTMF system is updated with country, site, contact, and applicable TMF document requirements.
• Collaborates with the Project Manager and Functional Leads to ensure timely and high-quality submission of TMF documentation, maintaining an inspection-ready state. Anticipates TMF compliance challenges and addresses risks proactively.
• Monitors and reports on TMF Health to internal teams and sponsors, identifying trends, risks, and overall TMF status.
• Serves as the point of contact and Subject Matter Expert (SME) for project audits or inspections, supporting report responses and escalating significant risks to TMF management.
• Performs Quarterly Completeness/Compliance checks for assigned projects and ensures proper documentation.
• Identifies and addresses TMF training needs for the project team, providing or supporting re-education.
• Manages close-out activities, including defining timelines for final document submission, processing, resolving queries, and transferring the eTMF export to sponsors.
• Provides training and education on good documentation practices and TMF for Clinical Solutions functions.
• Manages projects within the Sponsor eTMF Systems and offers solutions for challenges.
• Supports process development or improvement initiatives within the Records Management department and mentors junior team members.
• Acts as a System Superuser and performs assigned activities within tickets.