Overview

In 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.

Responsabilidades

- Provide 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 principales
- University 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 (Barcelona)
🏢 Trial Form Support
📍 Barcelona