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eTMF (Veeva Vault) Developer - Remote

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SmartIMS Inc.

2021-12-03 08:52:05

Job location Washington, District of Columbia, United States

Job type: fulltime

Job industry: Healthcare & Medical

Job description

*** 100% Remote Role ***

  • Bachelor's degree in related area; and/or equivalent experience/training.
  • At least five (5) years of eTMF System development and configuration experience required, including experience in study start-up, system setup, maintenance and closeout activities.
  • Subject matter expertise with the TMF Reference Model, clinical trial activities and related terminology.
  • Demonstrated experience with CTMS, EDC, and eTMF technologies.
  • Extensive knowledge and application of ALCOA FDA standards, Good Clinical Practice, and Good Documentation Practice, per ICH (E6 (R2).
  • Experience in clinical trials related roles (i.e. clinical operations and project management) or managing a clinical trial project. Has an understanding of clinical study phases involved in Drug Development and the corresponding records requirements, in accordance to federal regulations.
  • Highly proficient in CTMS and eTMF technologies. Experience and skills in navigating EDCs preferred.
  • Demonstrated understanding of the clinical study phases involved in Drug Development and the corresponding records requirements, in accordance to federal regulations.
  • Thorough knowledge and ability to apply all relevant Federal, state, and university regulations, policies, and federal guidance documents.
  • Thorough knowledge and experience with quantitative and qualitative research design; scientific research concepts and terminology.
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