Manager, TMF
ICON plc
full-time
Posted on:
Location Type: Remote
Location: Massachusetts • United States
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Tech Stack
About the role
- 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.
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.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
TMF oversighteTMF managementquality controlreconciliationinspection supportclinical trial documentationreporting requirementsUAT testingcontinuous improvementrisk assessments
Soft Skills
interpersonal skillsorganizational skillsmulti-tasking skillsanalytical skillsproblem-solving skillswritten communicationverbal communicationcross-functional collaborationinfluencing stakeholderstraining abilities