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eTMF Specialist

Cambridge, Massachusetts

Post Date: 10/18/2017 Job ID: 1688 Job Category: Clinical: Clinical Operations and Development

Our client is seeking an eTMF specialist. This individual will be integral to performing quality control reviews of several study eTMFs, updating metadata as necessary, and tracking and querying missing/erroneous documentation to ensure that eTMFs are complete and exceed our internal standards and regulatory requirements.

Job  Responsibilities:
  • Conduct Quality Control (QC) review of clinical study documentation in the eTMF to assess 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 standards, and will ensure rapid retrieval of documents during regulatory inspections.
  • May provide input on the revision of TMF-related SOPs, WIs, and internal TMF-related tools.


Qualifications/Requirements:
  • Minimum of 3 years industry experience in supporting the operations of clinical studies, including duties related to records management and maintenance of TMF/eTMF (eTMF experience preferred)
  • Good working knowledge of FDA GCP, MHRA, and ICH regulations, guidelines, and standards governing regulated clinical research and good documentation practices.
  • Familiarity with the DIA TMF reference model
  • Thorough understanding of Essential Documentation
  • Prior experience with TrialInteractive eTMF is a plus
  • Ability to execute independently and follow-through to completion
  • Independently motivated and detail-oriented with good problem solving ability

Aaron Goldman
Clinical Recruiter

Aaron is a spirited guy who likes to make things happen. He has been a Clinical Recruiter for the past five years, and says his greatest reward comes when a candidate accepts an offer and he hears the excitement in their voice - You know you have helped someone change their life!
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