TMF Specialist

Posted 3 days ago

virtual vocationsDenver (CO)

Regulatory Affairs SpecialistsResearch and Development in Biotechnology (except Nanobiotechnology)

SENIORITY

Senior

About the role

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

Before you apply

Applying takes about a minute. These four things decide how fast it moves after that.

Your profile is current

It's what we read first. Occupations, seniority and locations matter more than a long history.

Two examples you can talk through

Not a portfolio — just two pieces of work where you can explain the decisions and what you'd change.

A number in mind

What you're on now and what would make you move. We negotiate better when we know both.

Your notice period

Employers plan around it, and it's the question that stalls offers most often.

Once you apply, someone reads it and calls you before anything reaches the employer — usually within two working days.