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quality assurance etmf mastercontrol ich-gcp veeva vault etmf📋 Description
- Maintain the electronic Trial Master File (eTMF) in accordance with ICH-GCP and SOPs
- Perform TMF quality checks for completeness, accuracy, currency, and consistency
- Track missing/incomplete documents and follow up with internal teams, CROs, and sites
- Support study startup, maintenance, and close-out activities from a TMF perspective
🎯 Requirements
- Bachelor’s degree in life sciences or related field
- 2–5+ years in clinical trials, TMF management, or clinical operations
- Strong working knowledge of ICH-GCP and global regulatory requirements
- Experience with eTMF systems (e.g., Veeva Vault eTMF, Wingspan, MasterControl)
- Excellent attention to detail and document quality
🎁 Benefits
- 100% employer-paid medical, dental, and vision premiums for you
- 401(k) with employer match
- Pre-tax commuter benefits (transit/parking)
- Flexible Spending Accounts (FSA)
- Hybrid work model with flexibility
- Flexible, take-what-you-need PTO and company holidays
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