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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 is responsible for ensuring compliance with Good Clinical Practice (GCP), ICH E6 Guidelines, and relevant regulatory requirements (21 CFR Parts 312 and 314, EMA Clinical Trials Directives) across multiple studies.
Key responsibilities include: developing and executing study TMF Plans and Document Indexes; collaborating with project managers and functional leads to ensure timely, high-quality TMF documentation submission; monitoring and reporting TMF health status to internal teams and sponsors; serving as the subject matter expert for audits and regulatory inspections; conducting quarterly completeness and compliance checks; managing study close-out activities including final document submission and archival; providing training and mentoring to junior Records Management team members; and supporting process improvement initiatives within the Records Management department.
The role requires managing competing priorities, anticipating compliance challenges, identifying early risk signals, and maintaining inspection-ready documentation standards. You will work with sponsor eTMF systems, act as a system superuser, and serve as the primary point of contact for TMF-related matters on assigned projects.
Minimum qualifications: 4-year college degree (ideally in business, science, or healthcare) plus 3–4 years of TMF/eTMF experience with at least 1 year as a TMF Lead. Required skills include proficiency in Microsoft Office (Outlook, Word, Excel, PowerPoint), professional-level English, and ideally experience with Veeva Vault. You must demonstrate strong interpersonal skills, self-motivation, attention to detail, ability to work independently and collaboratively, and professionalism in stakeholder interactions.
