Trial Master File Associate – Remote (EU)

About the role

Join TFS HealthScience’s Clinical Development Services team as a Trial Master File (TMF) Associate. Working remotely from anywhere in the EU, you will support the ophthalmology study teams by ensuring the TMF is organized, compliant, and ready for regulatory inspection.

Key responsibilities

• Notify study teams when the TMF is created and ready for document upload.
• Develop and maintain the study‑specific TMF Plan and provide related training.
• Perform QC2 checks, document reconciliation, and generate monthly TMF reports.
• Monitor TMF metrics, address issues, and ensure timely implementation of TMF processes.
• Adjust TMF Index/EDL as directed by the Project Manager.
• Coordinate monthly and quarterly TMF reconciliations and produce action plans.
• Oversee TMF AoR completion, transfer to the sponsor, and delivery to the TMF Functional Lead.
• Ensure continuous document submission and eTMF maintenance so the TMF remains inspection‑ready.

Required profile

• 1‑5 years of experience in a CRO or pharmaceutical environment with proven TMF management.
• Bachelor’s degree in Health Science, Document Management, or equivalent preferred.
• Knowledge of GCP/ICH guidelines.
• Strong written communication, organizational, and multitasking abilities.
• Proficient with standard computer and software tools.

Required skills

• eTMF systems
• Document Management

What we offer

• Competitive compensation package.
• Comprehensive benefits.
• Opportunities for personal and professional growth in a collaborative, innovative environment.