Trial Master Fie

Position Details

Role Title: Trial Master File (TMF) Data Specialist

Location: Barcelona (2 days onsite)

Start Date: Immediate

Duration: 6 months + possible extension

Workload: 40 hours/week

Project Environment

The successful candidate will join the Clinical Operations and Quality teams, working closely with Clinical Trial Managers, CROs, Regulatory Affairs, and Study Teams to ensure TMF documentation is maintained in accordance with applicable regulations and industry standards.

This is a highly collaborative role requiring strong attention to detail, excellent stakeholder management skills, and experience working within regulated Pharma or Biotech environments.

Key Responsibilities

• Manage, review, and maintain Trial Master File (TMF) documentation.
• Ensure TMF completeness, quality, and inspection readiness.
• Perform TMF quality control reviews and reconciliation activities.
• Track, identify, and resolve missing or incomplete documentation.
• Collaborate with study teams and external vendors to ensure timely filing of documents.
• Support audits and regulatory inspections.
• Generate TMF metrics, reports, and quality indicators.
• Work with eTMF systems and contribute to process improvements.

Required Skills

• 5+ years of experience managing Trial Master Files (TMF).
• Experience working with eTMF platforms (Veeva Vault TMF, Trial Interactive, Wingspan, or similar).
• Strong understanding of ICH-GCP and clinical trial processes.
• Experience performing TMF health checks and quality reviews.
• Previous experience in Pharma, Biotechnology, or CRO environments.
• Strong organizational and stakeholder management skills.
• Fluent English.

Nice to Have

• Experience with Veeva Vault TMF.
• Knowledge of inspection readiness processes.
• Experience supporting global clinical studies.
• Background in Clinical Operations or Clinical Document Management.