Clinical Documentation Specialist

TMF Specialist 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. As a TMF Specialist at ICON, you will be responsible for managing and overseeing Trial Master File (TMF) and record management activities, study closure, archival and retention. The role supports the compliant management of paper and electronic clinical trial records, TMF transfers and migrations, Investigator Site File (ISF) retention support, and inspection readiness in accordance with applicable regulatory requirements and company procedures. What You Will Do: Coordinate and oversee TMF study closure and archival activities, including monitoring TMF health, tracking closure activities, ensuring required EDL/placeholder reconciliation and milestone completion, coordinating TMF lock timelines, and providing final archival sign-off. Coordinate with internal stakeholders and external archival/records management vendors to support secure transfer, storage, retrieval, and disposition of clinical trial records. Coordinate the reconciliation, inventory, transfer, shipment, storage, retrieval, and archival of paper clinical trial records, ensuring appropriate chain of custody and traceability are maintained. Coordinate and support the TMF/SSU Compliance team with TMF transfers and migrations, including migration planning, document and metadata mapping, reconciliation, quality verification, issue resolution, and confirmation of successful transfer. Coordinate with study teams to reconcile TMF records when sites, countries, or trials are terminated early, ensuring all applicable records are identified, collected, and filed based on the circumstances of the early termination. Ensure all queries to the closure mailbox are responded to in a timely manner. Support the study teams with Investigator Site File (ISF) questions on retention requirements and storage. Serve as a subject matter resource for TMF archival and retention processes during audits and regulatory inspections, including supporting document retrieval of archived records. Support the TMF Director and TMF Specialists as needed. Your Profile: 10 years of experience in clinical trials research within the pharmaceutical industry. Bachelor's degree in a scientific, healthcare, life sciences, or related discipline, or equivalent relevant experience. Experience working within the Veeva Vault TMF and familiarity with other TMF systems. Experience with both paper and electronic clinical document management. Experience managing or supporting TMF transfers and migrations. Strong knowledge of ICH-GCP and applicable global regulatory requirements and guidance related to clinical trial records, TMF management, archival, and retention. Strong organizational skills and ability to manage multiple priorities. Detail-oriented and proactive problem-solving skills. Good written and verbal communication skills. Excellent Microsoft Office and record management system skills. Ability to work both independently and as part of a team in a fast-paced environment. Must be able to be on-site in the Delaware office monthly, with possible international travel up to 20%. What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. 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, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here #J-18808-Ljbffr