TMF Specialist
ICON · Wilmington, DE
Clinical OperationsFull-timeCompany career page
The apply link worked recently (not employer-confirmed).
Role summary
ICON seeks a TMF Specialist to manage Trial Master File and clinical trial records for studies in various phases. The role focuses on coordinating study closure, archival activities, records transfers, and ensuring regulatory compliance across paper and electronic systems.
What they're looking for
- 10 years of clinical trials experience in pharmaceutical industry
- Bachelor's degree in scientific, healthcare, or life sciences discipline
- Proficiency with Veeva Vault TMF and other TMF systems
- Experience managing both paper and electronic clinical documents
- Knowledge of ICH-GCP and global regulatory requirements for TMF management
- Strong organizational and detail-oriented problem-solving abilities
- Excellent Microsoft Office and records management system skills
What you'll be doing
- Coordinate TMF study closure, archival, and milestone tracking with regulatory compliance
- Manage transfers and migrations of clinical trial records with stakeholders and vendors
- Reconcile and track paper and electronic clinical documents with chain of custody maintenance
- Support TMF compliance team and provide subject matter expertise during audits and inspections
- Respond to closure mailbox queries and advise study teams on ISF retention requirements
Privacy & handoff
This role links to ICON's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.