TMF Specialist
Virtual Vocations Inc
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
Vacancy posted 2 days ago
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