Associate TMF specialist Job

Associate TMF Specialist is needed to perform the following duties:

· Assist in creation, maintenance and archival of Trial Master Files/ electronic Trial Master Files in accordance with Client Standard Operating Procedure (SOP), GCP, EMA and FDA regulations

· May coordinate with eTMF vendor for TMF set-up and processing of TMF documents and conduct eTMF query resolution.

· Routinely processes TMF records submissions for adherence to established SOPs, TMF Plans and roadmaps and verifies acceptability of records, level of filing, document type, and required metadata

· Confirms records which fail first level QC review are queried to the study teams and/or external vendors and follows up for response/action

· May assists in the collaboration with the internal cross-functional project team and vendors to resolve discrepancies and ensure timely completion of internal tasks, as they relate to TMF deliverables.

· May conducts quality control and/or completeness checks, in accordance with Client’s SOPs and operational best practices relating to document management, to ensure accuracy of files within TMFs

· May contribute in periodic and/or Sponsor QA reviews of the TMF and facilitates query resolution in a timely manner and may support the Inspection Readiness Team and Clinical Project/Trial Manager in tracking eTMF related activities/milestones/metrics

· Potentially assist in TMF review following close-out activities, identifies issues/findings, and completed remediation and/or

· May assist in the archiving of TMF documents; this may include shipping, retrieval, and tracking of documents approved for archiving to off-site storage; Maintain electronic logs which contain the location of study documents.

· May provide support to CRAs for the submission of site documents to the TMF

· Develops TMF knowledge with progression towards subject matter expert for eTMF systems

· Assists with any additional TMF associated projects as needed.

Bachelor's Degree is required in Pharmacy or Pharmaceutical Science or Pharmaceutics or Regulatory Affairs.

Health/Dental Benefits, Paid Holidays, Vacations, and Sick Leave