Serve as TMF Lead for complex, high-risk studies or programs.
Oversee TMF from start-up through close-out, transfer, archival.
Monitor TMF health via metrics, KPIs, and risk-based assessments.
Partner with PM and functional leads to manage TMF deliverables and risks.
Deliver TMF oversight reports and updates to sponsors on cadence.
Lead study-level audit and inspection readiness activities and support responses.

🎯 Requirements

Minimum 7-9 years TMF experience in CRO with an honours Bachelors.
Equivalent education and experience may be considered.
Strong knowledge of ICH-GCP, 21 CFR Part 11, EU CTR, and global regs.
TMF Reference Model and risk-based TMF management principles.
Experience with inspection readiness activities and TMF audits.
Experience leading eTMF platforms (Veeva Vault, Wingspan).
Certifications in clinical research/quality/regulatory (SOCRA/ACRP/RAPS/TMF).

Apply on employer's website

This employer gathers applications via their own applicant tracking system.

You will be redirected to an external application form.

Share job

Meet JobCopilot: Your Personal AI Job Hunter

Automatically Apply to Operations Jobs. Just set your preferences and Job Copilot will do the rest — finding, filtering, and applying while you focus on what matters.

Activate JobCopilot