ICON plc is a globally recognized healthcare intelligence and clinical research organization committed to advancing clinical development through innovation and excellence. With a strong focus on fostering an inclusive work environment, ICON plc is dedicated to shaping the future of clinical trials and medical research. Join us in our mission to drive progress in the healthcare industry.
Responsibilities in Job
As a TMF Specialist at ICON plc, you will play a crucial role in managing the Trial Master File (TMF) and ensuring compliance with regulatory standards. Your key responsibilities will include:
- Maintaining effective communication with clinical trial teams and CRO (Contract Research Organization) staff during trial start-up, maintenance, close-out, and archiving.
- Managing open Quality Issues (QIs) and ensuring the resolution of documents failing TMF quality control and TMF quality review.
- Handling Expected Document Lists (EDL) and tracking document counts throughout the life of assigned trials in collaboration with Clinical Trial Teams (CTTs) and CRO teams.
- Escalating non-compliance issues to the eTMF Manager when necessary.
- Providing scheduled and ad-hoc reports on TMF health metrics for eTMF Managers and clinical teams.
- Supporting the filing and management of TMF documents into the Moderna eTMF system.
- Maintaining the naming and filing guide for TMF documents.
- Conducting quality checks and content reviews of documents uploaded into the eTMF system.
- Assisting with inspection/audit preparation and remediation tasks.
- Participating in departmental and trial-specific meetings to ensure seamless TMF operations.
- Keeping up-to-date with the TMF Reference Model, industry best practices, and regulatory requirements.
- Completing administrative tasks and other document-related duties as assigned by the eTMF Manager.
Qualifications Required
To be considered for the TMF Specialist position at ICON plc, candidates must meet the following qualifications:
- A B.A./B.S. degree, preferably in science or healthcare.
- At least 1+ years of experience in eTMF document management, either in a specialized team or as a member of a clinical trial team (preferred).
- Basic knowledge of the DIA TMF Reference Model.
Skills & Competencies
Candidates should possess the following skills to succeed in this role:
- Strong organizational and prioritization skills to manage workload efficiently.
- Attention to detail in document management and quality control.
- Effective communication skills to collaborate with internal teams and CRO staff.
- Ability to provide timely reports and analysis on TMF health.
- Knowledge of clinical trial documentation requirements.
