TMF Lead/Senior TMF Lead

The TMF Lead/Senior TMF Lead is responsible for oversight, creation, management, and delivery of the eTMF in accordance with Good Clinical Practice (GCP), E6 ICH Guidelines, and other regulatory guidance documents, including 21 CFR Parts 312 and 314, EMA Clinical Trials Directives, and Precision Standard Operating Procedures (SOPs). The Senior TMF Lead may handle complex or 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 information related to countries, sites, contacts, and applicable TMF document requirements.
• Collaborates with the Project Manager and Functional Leads to ensure timely and high-quality submission of TMF documentation, maintaining the TMF in an inspection-ready state. Anticipates challenges to TMF compliance and addresses risks proactively.
• Monitors and reports on TMF Health to internal teams and sponsors, identifying trends, risks, and overall status of the TMF.
• 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.
• Initiates and performs Quarterly Completeness/Compliance checks for assigned projects and ensures proper documentation.
• Identifies project team TMF training needs and provides or supports team re-education.
• Manages close-out activities of assigned studies, including defining timelines for final document submission, processing, and closing all outstanding queries.
• Provides training and education to Clinical Solutions functions on good documentation practices and TMF for clinical trials.
• Manages projects within the Sponsor eTMF Systems and delivers insightful solutions for challenges.
• Supports process development or improvement initiatives within the Records Management department and mentors junior team members.
• Acts as a System Superuser, carrying out assigned activities within tickets.