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eTMF Specialist in Cambridge, MA at Integrated Resources, Inc

Date Posted: 1/24/2019

Job Snapshot

Job Description

By reviewing and overseeing our eTMFs, this role is integral to ensuring that our files are complete and exceed our internal standards and regulatory requirements.
  • Conduct Quality Control (QC) review of clinical study documentation in the eTMF to assess completeness of the TMF, adequacy of documentation, accuracy of filing based on TMF table of contents, consistency with naming conventions, and completeness of metadata.
  • Generate prompt QC status reports and communicate the results to the study team leads.
  • Ensure timely resolution of QC findings and track progress.
  • Ensure eTMF structures are in compliance with regulatory guidance, internal bluebird bio standards, and will ensure rapid retrieval of documents during regulatory inspections.
  • Provide input on the revision of TMF-related SOPs, WIs, and internal TMF-related tools.