Job Summary and Purpose:

TMF Lead is responsible for supporting project teams in maintaining a high quality TMF in accordance with Good Clinical Practice (GCP), other guidance documents, and Precision Standard Operating Procedures (SOPs). Senior TMF Lead takes on responsibility for the complex or challenging studies requiring an experienced TMF Lead. Additionally, the Senior TMF Lead supports and mentors more inexperienced TMF Leads. 

Main Duties & Responsibilities:

• Ensure that TMF document review and processing, periodic quality review, set up, maintenance, finalization and archival of study TMFs is completed in a timely manner and with a high quality.
• Create and execute the study TMF Plan and project TMF Document Index. Ensure entire study team understands expectations, project-specific aspects of the TMF, and manage communication of any changes in the TMF Plan or Index to the project team.
• Ensure that TMF documentation (e.g. TMF Plan, TMF Index, Periodic Quality Review documentation) is filed in the TMF.
• Attend and contribute to project kick-off meetings, project internal or external meetings, and ad hoc meetings as needed to ensure the project team is aware of the status of the TMF, potential gaps and escalations.
• Engage and collaborate with the Project Manager and Functional Leads to ensure TMF documentation is submitted in a timely manner and with high quality in order to maintain the TMF in an inspection-ready state.
• Proactively anticipate challenges to TMF compliance and identify early signals of risk. Develop and implement plans to increase compliance and follows-up on non compliance. Follows TMF escalation process as needed.
• Ensure that TMF Risks are identified and appropriately documented and mitigated.
• Monitor and report on TMF Health and Metrics and escalate non-compliances and potential issues to internal team and Senior Leadership as required. Identify trends, risks, and overall status of the TMF and suggest mitigation strategies.
• Serve as point of contact and Subject Matter Expert (SME) for project audits or inspections and support in the report responses. Participate in Audit/Inspection interview. Escalate to TMF management in cases of significant risk to Precision.
• Ensure provision of TMF analytics and expertise to Sponsors.
• Ensure that Periodic Quality Review for assigned projects is initiated and performed by the Quality Review Specialists and ensure proper documentation.
• Ensure that document review and processing for assigned projects is performed by the Document Specialists on a timely and consistent basis.
• Identify project team TMF training needs and provide or support team re-education.
• Manage the close-out activities of assigned studies, including defining the timeline for final document submission, final document processing, close out of all outstanding queries, requesting the eTMF export from the vendor, transfer to the sponsor and collect the Acknowledgement of Receipt.
• Manage projects within the Sponsor eTMF System and actively listen to deliver insightful solutions for challenges.
• Monitor and report potential out of scope activities related to Records Management, communicate these to the TMF manager and Project Manager, and ensure out of scope tasks are properly added to change orders, if needed.
• Support and mentor less experienced TMF Leads on the performance of their role and problem-solving study-specific issues.

Minimum Education & Experience:

Bachelor’s degree (or its international equivalent) +5 years of related experience or equivalent combination of education, professional training and experience that provides the individual with the required knowledge, skills, and abilities to perform the job.

 Knowledge, Skills, and Competencies:

• Working knowledge of FDA & ICH/GCP regulations and guidelines
• Demonstrates solid interpersonal skills
• Ability to identify issues and escalate appropriately and effectively
• Excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines
• Manage competing priorities effectively
• Demonstrates, or is able to be trained and retain a working knowledge of ICH-GCP, and relevant Precision SOPs and regulatory guidance
• Exhibits strong self-motivation, is detail-oriented and able to work and plan independently as well as in a team environment
• Demonstrates professionalism, as evidenced by punctuality, ability to deliver on commitments, and maintain positive interactions with internal and external stakeholders
• Communicates both verbally and in written form in an efficient and professional manner
• Demonstrates values and a work ethic consistent with Precision Values and Company Principles