The Senior TMF Manager provides strategic leadership and hands-on oversight of the Trial Master File across multiple clinical trials to ensure inspection readiness
Job Summary
The Senior TMF Manager provides strategic leadership and hands-on oversight of the Trial Master File across multiple clinical trials to ensure inspection readiness.
This role drives standardization, defines best practices, and ensures compliance with global regulatory requirements including ICH-GCP, FDA, and EMA.
Candidates will lead eTMF system implementations, define governance frameworks, and collaborate cross-functionally to elevate TMF quality and operational efficiency.
Matching Summary
The Senior TMF Manager provides strategic leadership and hands-on oversight of the Trial Master File across multiple clinical trials to ensure inspection readiness.
Skills & Requirements
Must-have
8+ years clinical research experience
5+ years TMF management experience
eTMF system implementation leadership
ICH-GCP and FDA/EMA compliance knowledge
Veeva Vault platform expertise
Nice-to-have
Strong stakeholder management capabilities
Cross-functional collaboration skills
Passion for dermatology innovation
Data-driven process optimization mindset
Key Requirements
Bachelor's degree in Life Sciences required
Advanced degree (MSc, PhD) preferred
Proven track record supporting FDA and EMA inspections
Experience with CTMS, LMS, and other clinical systems integrations