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edc sdtm epro change control cdash
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📋 Description

  • Build EDC system structure, workflow, edit checks and user roles
  • Manage randomisation, ePRO licensing/validation/translation
  • Handle IMP management and targeted Source Data Verification
  • Develop study-level EDC docs and post-live changes
  • Follow Change Control for updates to EDC and reporting tools

🎯 Requirements

  • Zelta v2.0 experience is essential
  • Bachelor’s in Life Sciences or related field
  • Experience in EDC system creation and edit check programming
  • Strong communication and team collaboration
  • Self-motivation and ability to work independently
  • CDASH and SDTM data standards knowledge; CDASH certification preferred

🎁 Benefits

  • European location flexibility; position available in European locations
  • Collaborative, diverse global team in pharma and CRO context
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