Senior TMF Lead—Sponsor-Side Oversight & Archive

TFS HealthScience; Barcelona; On-site; EUR 70,000 - 100,000; Full time

Job summary

TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their clinical development journey. The Senior TMF Associate provides autonomous sponsor-side oversight of TMF activities across assigned studies and supports compliant management of the R&D archive.

The role collaborates with CROs, study teams, Quality and IT to ensure TMF quality, inspection readiness and traceability.

Qualifications

• University degree in Life Sciences, Information Management, Library or Archival Science.
• Fluent professional English.
• Minimum 6+ years of TMF/clinical documentation experience.
• Autonomous sponsor-side or equivalent oversight across multiple studies.
• Experience with TMF quality metrics, issue management, transfers and archiving.
• Working knowledge of Veeva Vault eTMF or eTMF Archive; ICH-GCP and GxP principles.
• Ability to work independently and manage competing priorities.

Responsibilities

• 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 coordinate corrective follow-up.
• Guide study teams and CROs on TMF responsibilities and inspection readiness.
• Coordinate TMF transfers, mapping, reconciliation and risk-based post-transfer verification.
• Support Veeva Vault eTMF Archive activities, including study setup, access, UAT and operational support.
• Maintain portfolio tracking of TMF locations, transfers and archive records.
• Draft and improve TMF SOPs, Work Instructions, templates and training materials.
• Maintain the R&D archive and coordinate custody, retrieval and shipments.
• Support audits and inspections and provide status updates on risks and actions.

Skills

TMF oversight

Independent work

Prioritization

Documentation quality

Education

Life Sciences / Archival Science degree

Tools

Veeva Vault eTMF

Job description

TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their clinical development journey. The Senior TMF Associate provides autonomous sponsor-side oversight of TMF activities across assigned studies and supports compliant management of the R&D archive.

The role collaborates with CROs, study teams, Quality and IT to ensure TMF quality, inspection readiness and traceability.