Ergomed seeks an EDC Developer to design and build electronic data capture systems for clinical trials using Medidata RAVE and Zelta v1.0. The role involves creating system structures, workflows, edit checks, documentation, and managing post-launch updates under the Data Management department.
Responsibilities
- Design EDC system structure, workflows, edit checks, and user roles based on study protocol and data standards
- Configure randomization, ePRO, IMP management, and targeted SDV functionality as needed
- Create study documentation including specifications, test plans, and training materials
- Execute post-launch system changes and updates following change control procedures
Requirements
- Medidata RAVE and Zelta v1.0 experience
- Bachelor's degree in Life Sciences, Pharmacy, or related health discipline
- Prior EDC system creation and edit check programming experience
- Proficiency in CDASH and SDTM data standards
- Strong communication and teamwork skills
- Self-motivated with independent work capability
- CDASH Certification preferred