Trial Master File Specialist (TMFS) II/Snr TMF - TMF and ALCOA principles experience required

Ergomed seeks a Trial Master File Specialist II/Senior TMF to establish, maintain, and ensure quality of trial documentation. The role manages TMF-related activities across assigned projects, performs document processing and quality checks per ALCOA+ principles, and supports audit preparations and archiving.

Responsibilities

• Set up, maintain, and manage Trial Master Files for assigned projects
• Process, index, and quality-check project documents according to SOPs and ALCOA+ principles
• Serve as primary contact for all TMF-related inquiries and activities
• Support study audits, review audit reports, and oversee corrective and preventative action plans
• Prepare study closure activities including TMF reconciliation, file shipping, and archiving

Requirements

• Trial Master File maintenance and quality check experience
• Demonstrated knowledge of ALCOA principles
• Administrative experience in international clinical research setting
• Advanced Excel proficiency
• Ability to independently manage TMF quality oversight and follow-up
• Excellent English oral and written communication skills