job title: TMF specialist(icon)

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