TMF Specialist

TMF Specialist

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

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%.

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

Visit our careers site to read more about the benefits ICON offers.

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.

Are you a current ICON Employee? Please click here to apply