13 days ago
Remote, United KingdomMid Level
Responsibilities
- Create EDC systems for complex projects, including structure, workflows, edit checks, and user roles and permissions.
- Implement applicable randomization, ePRO, IMP management, targeted SDV, and other non-core EDC functionality.
- Create EDC specifications, test plans, study-specific training materials, and other study-level documentation.
- Perform post-live EDC and reporting application changes under a change-control process.
- Apply CDASH, SDTM, study protocols, and standard eCRF templates to EDC system creation.
Requirements
- Essential: Zelta v2.0 experience.
- Prior experience creating EDC systems and programming edit checks.
- Graduate or bachelor’s degree in Life Sciences, Pharma, or a related health discipline.
- Proficiency in CDASH and SDTM data standards and their application to EDC system creation.
- Effective communication, teamwork, self-motivation, and the ability to work independently.
- CDASH certification is preferred.
Benefits
- Full-time six-month contract.
- Position available in any of the company’s European locations.
- Collaborative work with experts in clinical research, pharmacovigilance, and quality consulting.
