Senior Clinical Trial Associate

TFS HealthScience; Barcelona; Hybrid; EUR 52,000 - 75,000; Full time

Benefits offered by this job

Hybrid work arrangement

Job summary

TFS HealthScience is seeking a Senior CTA / Senior TMF Associate for our Barcelona office. The role provides sponsor-side TMF oversight across studies, ensuring quality, transfer and archiving, with a hybrid work arrangement (3 days in office, 2 remote).

Join a global CRO with over 30 years in the industry, supporting regulatory readiness and archive management across multiple therapeutic areas.

Qualifications

• University degree in Life Sciences or related field.
• 3-4 years of TMF/clinical documentation or clinical operations experience; direct TMF responsibility.
• Demonstrated autonomous sponsor-side oversight across multiple studies.

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 actions.
• 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 and operations.

Education

University degree in Life Sciences, Information Management, Library or Archival Science

Minimum 3-4 years TMF/clinical documentation/clinical operations experience

Job description

SENIOR CTA / SENIOR TMF ASSOCIATE - BARCELONA (SPAIN)

Hybrid work arrangement (3 days in the office, 2 remote)

About this role

TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full-service capabilities, resourcing, and Functional Service (FSP) solutions. The Trial Master File Associate provides autonomous sponsor-side oversight of TMF activities across assigned clinical studies and supports compliant management of the R&D archive. The role works with CROs, study teams, Quality and Information Technology to maintain TMF quality, inspection readiness, reliable transfer and archiving, and clear traceability of risks, decisions and actions.

CORE RESPONSIBILITIES

• 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.

REQUIRED EDUCATION AND EXPERIENCE

• University degree in Life Sciences, Information Management, Library or Archival Science, or a relevant discipline.
• Minimum 3-4 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.

What We Offer

We provide opportunities for personal and professional growth in a rewarding environment. You will join a team that values collaboration, quality, and making a difference in the lives of patients.

Our core values of Trust, Quality, Passion, Flexibility, and Sustainability guide our decisions and shape our culture. By aligning on these values, we foster collaboration, innovation, and a shared commitment to excellence. Together, we make a difference.

A Bit More About Us

Our journey began over 30 years ago in Sweden, in the city of Lund. As a full-service global CRO, we build solution-driven teams working toward a healthier future. Bringing together over 600 professionals, TFS delivers tailored clinical research services in more than 50 countries, offering flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.