TMF Specialist
Job Summary
To support Regulatory Operations, the full-time remote TMF Specialist will manage, review, and approve site-level documentation within the electronic Trial Master File (eTMF), ensuring compliance and audit readiness throughout the study lifecycle.
Key responsibilities
- Review and approve TMF documents, ensuring alignment with study-specific filing requirements and document quality standards
- Communicate with internal stakeholders to resolve document discrepancies and maintain a complete, inspection-ready TMF
- Participate in TMF audit preparation and support process improvement efforts to enhance document quality and compliance
Required qualifications
- Bachelor's degree in biological sciences or a related field preferred
- At least 1 year of experience in clinical research, document management, or regulatory operations
- Experience with electronic document management systems and eTMF platforms, particularly Veeva Vault, strongly preferred
- Familiarity with Good Clinical Practices (GCP), ICH guidelines, and the DIA TMF Reference Model is desirable
Complete Job Description
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