TMF Quality & Compliance Specialist (eTMF)

Jobtailor

California (MO)

On-site

USD 85,000 - 120,000

Full time

10 days ago

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Job summary

Jobtailor is seeking a skilled TMF specialist to manage Trial Master Files in regulated clinical environments. You will maintain eTMF documents, perform quality control reviews, and ensure inspection-ready filing.

Collaborate with Clinical Operations, CROs, and vendors to align on document flow and TMF expectations. You will monitor TMF health metrics, drive timely resolutions, and support audits, FDA inspections, and regulatory inquiries.

Qualifications

Bachelor’s degree in Life Sciences, Health Sciences, or related field or equivalent.
2–4+ years of TMF management or clinical document management experience in biotech/pharma/CRO.
Experience maintaining electronic TMF (eTMF) in regulated clinical trials.
Hands-on experience with Veeva Vault eTMF or similar platforms.
Familiarity with ICH-GCP, 21 CFR Part 11, CDISC TMF, and FDA/global regulations.

Responsibilities

Maintain assigned study TMFs, ensuring filing accuracy and contemporaneous documentation per TMF standards.
Perform routine QC reviews to identify missing, incomplete, or misfiled documents and drive timely resolution.
Monitor TMF health, completeness, and timeliness; communicate risks and trends to stakeholders.
Partner with Clinical Operations, CROs, vendors on document flow and TMF filing expectations.
Support TMF transfers, reconciliation, and vendor/CRO reconciliation activities.
Assist audits/regulatory inspections by maintaining inspection-ready documentation.
Track and resolve TMF queries, issues, and corrective actions.
Support TMF plans, SOPs, work instructions, and related documentation.
Assist with user training and adoption of eTMF systems and processes.