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

Novi Sad, Vojvodina, rsFull-time2026-10-15 → 2026-11-10

Core

Maintains and manages the Trial Master File (TMF) for clinical research projects, ensuring document quality and compliance with ALCOA+ principles.

Role type

Clinical Trial Master File Specialist

Builds

Trial Master Files (TMF) for clinical studies

Domain

Clinical Research / Pharmaceutical

Required skills

TMF maintenance, ALCOA principles, document indexing, quality assurance, audit support, report preparation, Excel proficiency, English communication

Preferred skills

International clinical research experience, ability to work independently

Technologies

Excel

Responsibilities

Set up and maintain TMF, process and index project documents, perform quality checks using ALCOA+ principles, assist in TMF reconciliation and archiving, support study audits and prepare corrective action plans, prepare status reports.

Seniority

Mid-level, hands-on specialist

About Ergomed

Ergomed is a specialist clinical research organization focused on rare disease and select oncology indications. We focus on the most complex trials, the studies where experience, judgement, and rigorous operational accountability make the biggest difference. We partner with small to midsize biotech companies to move promising therapies through early phase development, so they reach the patients sooner.