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Ergomed
Trial Master File Specialist II/Snr Tmf
Remote · Poland · Full time · Mid level
About the role
Assist with setup and maintenance of Trial Master File (TMF) and serve as main contact for TMF activities. Ensure TMF quality and support audits and reconciliation upon study closure.
What you’ll do
• Set up and maintain Trial Master File. • Serve as main TMF contact for assigned projects. • Process and index TMF documents per guidelines. • Assist in TMF reconciliation and archiving. • Support audit preparations and corrective actions.
What you’ll bring
• Experience in TMF maintenance and quality check. • Knowledge of ALCOA principles. • Administrative experience in clinical research preferred. • Proficiency in Excel. • Very good English communication skills.
Life at Ergomed
Ergomed values quality, integrity, passion, agility, belonging, and collaboration. They offer a supportive, international team with a focus on work-life balance.
About Ergomed
Ergomed is a specialist clinical research organization focused on rare diseases and oncology, partnering with biotech companies to advance complex trials and therapies.