Senior TMF Lead

Job Summary

Providing expert TMF oversight for assigned studies, the full-time Senior TMF Lead will ensure TMF quality, compliance, and continuous inspection readiness while working remotely and mentoring staff across multiple locations.

Key responsibilities

• Serve as TMF Lead for complex studies, providing end-to-end oversight from study start-up through close-out
• Align sponsor-specific TMF requirements with CRO processes and ensure consistent TMF execution across assigned studies
• Develop and deliver advanced TMF training materials while mentoring TMF staff to ensure adherence to standards

Required qualifications

• Minimum 7-9 years of experience in TMF function within a Contract Research Organization, along with an Honour's Bachelor's degree
• Strong knowledge of ICH-GCP, 21 CFR Part 11, EU CTR, and global regulatory requirements
• Experience with inspection readiness activities and TMF audits
• Familiarity with leading eTMF platforms, such as Veeva Vault or Wingspan
• Certifications related to clinical research or regulatory compliance are a plus