OverviewIn this role, you oversee sponsor-side TMF activities across clinical studies to ensure inspection readiness and reliable R&D; archiving.
You collaborate with CROs, study teams, QA, and IT to maintain TMF quality and traceability.
You will guide teams on TMF responsibilities, support transfers and verification, and contribute to SOPs and training.
The position sits within the SRS/FSP group, focusing on a single sponsor with integral reach.
You drive compliant, timely TMF outcomes that support regulatory readiness and study success.
ResponsabilidadesProvide sponsor-side TMF oversight from study setup 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 drive corrective actions
Guide study teams and CROs on TMF responsibilities and inspection readiness
Coordinate TMF transfers, mapping, reconciliation and post-transfer verification
Support Veeva Vault eTMF Archive activities, including study setup, access, UAT and ops 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 with concise risk/status updates
Requisitos principalesUniversity degree in Life Sciences, Information Management, Library or Archival Science, or a relevant discipline
Fluent professional English
Minimum 6+ years of TMF/clinical documentation or clinical operations experience with direct TMF responsibility
Autonomous sponsor-side or equivalent oversight across multiple studies and CRO models
Experience with TMF quality metrics, issue management, transfers, reconciliation, verification and archiving
Working knowledge of Veeva Vault eTMF or eTMF Archive and of ICH-GCP, GxP and ALCOA+ principles
Ability to work independently, manage competing priorities and deliver traceable outputs
Independent working style
Prioritization and multitasking
Clear, traceable communication
TMF oversight and governance
Veeva Vault eTMF/eTMF Archive
ICG-GCP, GxP, ALCOA+ principles

📌 Senior Tmf Associate (España)
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📍 España