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TMF Operations Lead
PraxisprecisionmedicinesGenetic Therapies company
Remote$99,000 - $119,000 USDLead
Eventide Asset Management
Vida Ventures
Novo Holdings
Blackstone Life Sciences
OCV Partners
Avoro Capital Advisors
Operations & Strategy
About the role
TL;DR
Lead TMF operations, ensuring documentation is complete and inspection ready.
- •The TMF Operations Lead ensures clinical trial documentation is complete, accurate, timely, and inspection ready.
- •You will partner with cross-functional teams to build high-quality TMFs and identify risks early.
- •Key Responsibilities Serve as the TMF subject matter expert and provide guidance on TMF requirements.
- •Lead the setup, maintenance, quality review, and closeout of electronic Trial Master Files.
- •Monitor TMF health, completeness, and quality, translating metrics into insights and actions.
- •Partner with stakeholders to resolve TMF gaps and ensure timely filing.
- •Requirements Bachelor's degree in life sciences, healthcare, or related field.
- •At least 5 years of progressive experience in TMF operations or management.
- •Strong experience with electronic TMF platforms; Veeva Vault eTMF preferred.
- •Deep working knowledge of ICH-GCP, FDA requirements, and global regulations.
Domain expertise
biotechhealthcare