TMF Specialist (all levels)

Manage, set up, and maintain the Trial Master File (TMF/eTMF) for assigned global clinical trials throughout the entire study lifecycle.

Ensure completeness, quality, and data integrity of all essential clinical study documents in strict compliance with ICH-GCP regulations and standard operating procedures.

Collaborate cross-functionally with study teams, clinical project managers, and investigators to ensure timely collection, processing, quality control, and filing of trial records.

Conduct regular TMF gap analyses, document quality reviews, and mock audits to guarantee continuous inspection readiness for sponsor audits and health authority inspections (e.g., FDA, EMA, MHRA).

Provide technical guidance and operational support on TMF-related workflows, filing conventions, and DIA TMF Reference Model standards.

Guide and mentor junior document management coordinators across clinical study portfolios.

Utilize electronic Document Management Systems (eDMS) and modern cloud-based eTMF software platforms to track and archive trial assets.

Comprehensive total rewards including competitive base salary, performance incentives, medical/dental/vision coverage, pension plans, life assurance, and structured global learning pathways.