Study Management Specialist

Wilmington, DE 19805

Posted: 08/14/2019 Industry: Other Area(s) Job Number: 36350

Study Management Specialist 
  • 3-5 years of experience in clinical trial DOCUMENT MANAGEMENT and regulatory documents is required
  • Veeva experience a plus

  • Operational responsibility to set-up the local Trial Master File (eTMF) and Investigator Site File including tracking of documents.
  • Maintain and close the local TMF (in electronic or paper form depending on study) ensuring International Conference of Harmonization Guidelines for Good Clinical Practice (ICH/GCP) compliance and local requirements.
  • Support the CRA in the maintenance and close out activities for the ISF.
  • Contribute to the production and maintenance of study documents, ensuring template and version compliance.
  • Contribute to electronic applications/submissions by handling clinical-regulatory documents according to the requested technical standards i.e. Submission Ready Standards (SRS), supporting effective publishing and delivery to regulatory authorities (not for international studies).
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