TMF Specialist (all levels)

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

Ensure absolute completeness, accuracy, data integrity, and quality of essential clinical study documents in compliance with ICH-GCP guidelines and regulatory requirements.

Collaborate cross-functionally with clinical project managers, CRAs, and study teams to ensure timely collection, processing, QC review, and filing of trial records.

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

Serve as the dedicated subject matter expert on TMF-related operational guidelines, filing conventions, and DIA TMF Reference Model standards.

Provide technical guidance and mentorship to junior document management coordinators and cross-functional study team members.

Manage and maintain electronic document management systems (eDMS) and specialized eTMF platforms.

Comprehensive total rewards including competitive base salary, performance incentives, health and medical coverage (dental and vision included), retirement/pension plans, and structured global learning pathways.