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Precision for Medicine is seeking an experienced TMF (Trial Master File) Lead or Senior TMF Lead to oversee the creation, management, and delivery of electronic TMF (eTMF) systems for clinical trials. This role ensures compliance with Good Clinical Practice (GCP), ICH E6 Guidelines, FDA regulations (21 CFR Parts 312 and 314), EMA Clinical Trials Directives, and company SOPs.
Key responsibilities include: developing and executing study TMF Plans and Document Indexes; attending project kick-off and status meetings to communicate TMF expectations and changes; maintaining eTMF systems with accurate country, site, contact, and document requirement information; collaborating with Project Managers and Functional Leads to ensure timely, high-quality document submission and inspection-readiness; monitoring and reporting TMF health metrics and identifying compliance risks; serving as SME for audits and regulatory inspections; performing quarterly completeness and compliance checks; identifying and delivering TMF training needs; managing study close-out activities including final document submission and sponsor transfers; providing training to clinical teams on documentation practices; managing projects within sponsor eTMF systems; supporting process improvement initiatives; mentoring junior Records Management staff; and serving as system superuser for assigned tickets.
The Senior TMF Lead may assume responsibility for complex or challenging studies and supports development and implementation of TMF-related processes and systems.
Required qualifications: 4-year college degree (ideally in business, science, or healthcare); 3–4 years TMF/eTMF experience with at least 1 year as a TMF Lead; proficiency in Microsoft Office (Outlook, Word, Excel, PowerPoint); professional-level English; ideally Veeva Vault experience. Essential competencies: strong interpersonal and communication skills; working knowledge of ICH-GCP and regulatory guidance; ability to manage competing priorities; self-motivation; detail-orientation; professionalism; and sound judgment on escalations.
