13 days ago
Remote, Romania or Bucharest, RomaniaMid Level
Responsibilities
- Create EDC systems covering structure, workflows, edit checks, and user roles and permissions.
- Configure applicable functionality including randomisation, ePRO, IMP management, targeted SDV, and other non-core EDC features.
- Prepare EDC specifications, test plans, study-specific training materials, and other study-level documentation.
- Perform post-live EDC and reporting-application changes under the change-control process.
- Apply CDASH and study protocols to EDC system creation.
Requirements
- Essential experience with Zelta v2.0.
- Prior experience creating EDC systems and programming edit checks.
- Graduate or bachelor’s degree in life sciences, pharma, or a related health discipline from an accredited institution.
- Proficiency with CDASH and SDTM data standards and their application to EDC system creation.
- CDASH certification is preferred.
- Effective communication, cooperation, teamwork, self-motivation, and ability to work independently.
Benefits
- Full-time six-month contract.
- Position available in any of the company’s European locations.
- Collaborative work with clinical research, pharmacovigilance, and quality consulting professionals.
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