Remote TMF Operations Lead – eTMF Expert

Scorpion Therapeutics

Boston (MA)

On-site

USD 99,000 - 119,000

Full time

14 days+

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Job summary

Scorpion Therapeutics in the United States is seeking a TMF Operations Lead to guide TMF requirements throughout the clinical trial lifecycle. You will own the setup, maintenance, quality review, and closeout of electronic Trial Master Files (eTMF) and ensure they are inspection-ready.

This role emphasizes monitoring TMF health, partnering with Clinical Operations and external vendors, addressing gaps, and driving timely filing.

Qualifications

5+ years progressive TMF operations/management experience in biotech/pharma/clinical research.
Deep knowledge of ICH-GCP, FDA requirements, and global TMF regulations.

Responsibilities

Serve as TMF subject matter expert and trusted partner, providing guidance on TMF requirements, expectations, and best practices throughout the clinical trial lifecycle.
Lead setup, maintenance, quality review, and closeout of electronic Trial Master Files (eTMFs) ensuring they are complete, accurate, contemporaneous, and inspection ready.
Monitor TMF health (completeness, timeliness, quality) against study milestones; translate metrics into insights, risks, and recommended actions.
Partner with Clinical Operations, external vendors, and cross-functional stakeholders to maintain document lists, resolve gaps, and ensure filing within timelines.
Identify, investigate, and drive resolution of TMF issues (missing/late/poor-quality); escalat[??].
Support inspection readiness (audits and regulatory inspections) by ensuring TMF documentation/processes meet applicable global requirements.
Contribute to continuous improvement of TMF procedures, work instructions, training, systems, and operating practices.