TMF Lead

About the role

Precision Medicine Group is hiring a TMF Lead to support project teams in maintaining a high-quality Trial Master File (TMF) in line with Good Clinical Practice (GCP), other guidance documents and Precision SOPs. The role covers the full TMF lifecycle, from creation and maintenance to audit support and study close-out, and the Senior TMF Lead also mentors less experienced leads.

Key responsibilities

• Ensure timely, high-quality TMF document review, periodic quality review, setup, maintenance, finalization and archival of study TMFs.
• Create and execute the study TMF Plan and project TMF Document Index, keeping the project team informed of changes.
• File TMF documentation correctly and attend project meetings to keep the team aware of TMF status, gaps and escalations.
• Work with the Project Manager and Functional Leads to keep TMF submissions on time and inspection-ready, anticipating compliance risks and following the escalation process.
• Identify and mitigate TMF risks, monitor TMF health metrics and report trends and issues to leadership.
• Act as point of contact and subject matter expert for audits and inspections, support report responses and provide TMF analytics to sponsors.
• Ensure Periodic Quality Reviews are carried out by Quality Review Specialists and document review by Document Specialists, and train or support team re-education.
• Manage study close-out: timelines, final document processing, query resolution, eTMF export from the vendor, transfer to the sponsor and receipt acknowledgement.
• Mentor less experienced TMF Leads and report out-of-scope records management activities to the TMF manager and Project Manager.

Required profile

• Bachelor's degree (or international equivalent).
• 5 years of related experience, or an equivalent combination of education, training and experience.
• Legally authorized to work in the country of employment without employer sponsorship.

Required skills

• Working knowledge of FDA and ICH/GCP regulations and guidelines.
• Demonstrable or trainable knowledge of ICH-GCP and relevant Precision SOPs and regulatory guidance.
• Strong interpersonal, organizational and time-management skills, with the ability to work independently and in a team.