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

JOB FUNCTIONS/RESPONSIBILITIES

• Maintain effective communication with clinical trial teams and CRO staff throughout trial start-up, maintenance, close-out, and archive
• eTMF Health: Manage open Quality Issue (QI) lists for assigned trials to ensure documents which fail TMF quality control and/or TMF quality review are effectively remediated.
• Closes and reassigns QIs as necessary.
• eTMF Health: Manage Expected Document Lists (EDL) and counts for the life of assigned trials partnering with the Clinical Trial Team (CTT) and CRO team.
• Escalate non-compliance with EDL business process to the eTMF Manager as needed.
• eTMF Health: Provide scheduled and ad-hoc analysis and metrics on TMF Health for eTMF Managers and CTT/CRO teams on assigned trials.
• Be responsible for TMF activities for assigned trials including:
• Supporting TMF document filing into Moderna eTMF system.
• Maintaining the naming and filing guide specific to TMF documents.
• Conducting ad-hoc quality checks and review of document content uploaded into the eTMF.
• Responding to inquiries regarding TMF management and contents.
• Supporting inspection/audit preparation and remediation activities.
• Attend departmental and trial-specific meetings and discussions, as required.
• Maintain up to date knowledge of the TMF Reference Model, industry best practices and regulatory requirements.
• Performs general administrative tasks related to their assigned trials.
• Completes other TMF document-related tasks as required by the eTMF Manager or department head.

EXPERIENCE & SKILLS

• Minimum B.A./B.S. degree preferably in science or healthcare.
• 1+ years experience in eTMF document management (in a specialized team or as a member of a clinical trial team) is an advantage.
• Strong organizational/prioritization skills for the management of workload and attention to detail.
• Basic knowledge in DIA TMF Reference Model

What ICON can offer you: