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Manager, TMF
Location
Massachusetts
Posted
126 days ago
Salary
0
Seniority
Senior
Job Description
Manager, TMF
ICON plc
• Provide end-to-end oversight of the Trial Master File (internally and externally managed eTMF). • Serve as the eTMF business owner. • Ensure TMF completeness, accuracy, and timeliness in accordance with ICH-GCP, regulatory requirements, and internal SOPs. • Lead TMF quality review activities, including periodic QC, reconciliation, and ongoing completeness checks. • Ensure TMF inspection readiness and support internal, sponsor, and regulatory inspections and audits. • Manage and optimize TMF-related processes, standards, and SOPs. • Author and review clinical trial documentation, including TMF Management Plans, content list, study related plans, process documentation, training materials, etc. • Serve as a subject matter expert (SME) for the eTMF system, including configuration, taxonomy, metadata, and user adoption. • Develops requirements for reporting from the system, participate in UAT test script generation, UAT testing, and quarterly system update release review and approval. • Manage continuous improvement initiatives to enhance TMF quality, efficiency, and compliance. • Support TMF migrations, system upgrades, and vendor transitions as needed. • Partner with Clinical Operations, Clinical Trial Managers, Quality Assurance, cross functional members of the Clinical Sub-Team (CST) and external vendors to ensure TMF alignment and compliance. • Provide TMF guidance and training to internal teams and study partners. • Act as the primary TMF point of contact for assigned studies. • Manage CRO partners on eTMF-related activities. • Lead or mentor TMF managers, specialists, or vendors as applicable. • Contribute to TMF strategy, governance models, and global standards. • Support TMF-related risk assessments and mitigation plans.
Job Requirements
- Bachelor’s degree in Life Sciences, Health Sciences, or a related field required
- Advanced degree preferred
- 5+ years of clinical research experience with direct TMF or eTMF oversight
- Hands-on experience with TMF quality control, reconciliation, and inspection support
- In-depth knowledge of ICH-GCP, TMF Reference Model, and global regulatory requirements
- Strong experience with industry-standard eTMF systems (e.g., Veeva Vault TMF or similar)
- Proven ability to manage multiple studies and priorities in a fast-paced environment
- Proven ability to train new and experienced team members on appropriate system utilization and processes to support clinical systems and documentation
- Strong interpersonal, organizational, and multi-tasking skills
- Strong analytical, organizational, and problem-solving skills
- Excellent written and verbal communication skills
- Ability to work cross-functionally and influence stakeholders at all levels.
Benefits
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
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