Manager, TMF

ICON plc • Boston, MA

3d

About The Position

Manager, Trial Master File (Manager, TMF) ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development The Manager, Trial Master File (TMF) is responsible for the strategic oversight, operational management, and continuous improvement of the Trial Master File across clinical studies. This role ensures that TMF processes, systems, and documentation comply with global regulatory requirements (e.g., ICH-GCP, FDA, EMA) and support inspection readiness at all times. The position reports into Clinical Operations and partners cross-functionally with all functional areas part of the Clinical Sub Team (CST) accountable for the TMF, as well as external vendors to maintain a complete, accurate, and inspection-ready TMF.

Requirements

• Bachelor’s degree in Life Sciences, Health Sciences, or a related field required
• 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

Nice To Haves

• Advanced degree preferred

Responsibilities

• 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.

Benefits

• In addition to your competitive salary, ICON offers a range of additional benefits.
• Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
• Our benefits examples include: 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager