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Senior TMF Associate
TFS HealthScience - Contract Research Organization. Provide sponsor-side TMF oversight from study set-up through close-out, transfer and archiving .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in TMF oversight, including management of TMF completeness, quality, and timeliness, while ensuring compliance with ICH-GCP and GxP standards. Proficient in Veeva Vault eTMF operations and capable of drafting SOPs and training materials to support clinical documentation processes.
Highest-signal resume keywords
TMF OversightVeeva Vault eTMFICH-GCP KnowledgeClinical Documentation ExperienceIssue Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
TMF Completeness MonitoringTMF Quality MetricsDocument ManagementRisk-Based VerificationTMF Transfers CoordinationSOP DraftingClinical OperationsAutonomous OversightIssue ResolutionPortfolio Tracking
Soft Skills
Independent WorkPrioritizationClear CommunicationTeam CollaborationConcise Reporting
Tools & Technologies
Veeva VaultETMF ArchiveQuality Management SystemsDocument Tracking Systems
Industry Keywords
Life SciencesClinical TrialsGxPALCOA+ PrinciplesCRO Oversight
Tech Stack
Tools & technologiesVault
About the role
Key responsibilities & impact- Provide sponsor-side TMF oversight from study set-up through close-out, transfer and archiving
- Review TMF Plans, TMF Indexes, Expected Document Lists and CRO oversight arrangements
- Monitor TMF completeness, quality and timeliness; identify gaps and coordinate corrective follow-up
- Guide study teams and CROs on TMF responsibilities, document expectations and inspection readiness
- Coordinate TMF transfers, mapping, reconciliation and risk-based post-transfer verification
- Support Veeva Vault eTMF Archive activities, including study set-up, access, UAT and operational support
- Maintain portfolio tracking of TMF locations, transfers, archived records, findings and ownership
- Draft and improve TMF SOPs, Work Instructions, templates, checklists, guidance and training materials
- Maintain the R&D archive and coordinate custody, retrieval, shipments, records controls and archive vendors
- Support audits and inspections and provide concise status updates on risks, overdue actions and decisions
- Work with CROs, study teams, Quality and Information Technology to maintain TMF quality, inspection readiness, reliable transfer and archiving, and traceability of risks, decisions and actions
- Provide dedicated support to one global pharmaceutical or biotechnology sponsor through the SRS/FSP team
Requirements
What you’ll need- University degree in Life Sciences, Information Management, Library or Archival Science, or a relevant discipline
- Fluent professional English
- Minimum 6+ years of relevant TMF, clinical documentation or clinical operations experience, including substantial direct TMF responsibility
- Demonstrated autonomous sponsor-side or equivalent oversight across multiple studies and CRO delivery models
- Experience with TMF quality metrics, issue management, transfers, reconciliation, verification and archiving
- Working knowledge of Veeva Vault eTMF or eTMF Archive
- Working knowledge of ICH-GCP, GxP and ALCOA+ principles
- Ability to work independently, manage competing priorities and deliver clear, traceable outputs
Benefits
Comp & perks- Opportunities for personal and professional growth
- Rewarding environment
- Collaborative team culture
- Opportunity to make a difference in patients' lives