EDC Developer (Medidata RAVE and Zelta v1.0)
Core
Builds EDC application structures, workflows, edit checks, and user roles for complex clinical projects based on CDASH standards and study protocols.
Role type
EDC Developer (Clinical Data Management)
Builds
EDC systems (Medidata RAVE and Zelta), ePRO modules, IMP management tools, and reporting applications
Domain
Clinical Research / Biopharmaceuticals
Deliverable
production ML models | product features | dashboards & analysis
Required skills
EDC system creation, Edit Check programming, CDASH standards, Study protocol interpretation, eCRF template design, Change Control processes
Preferred skills
CDASH Certification, ePRO licensing and validation, Targeted SDV implementation
Technologies
Medidata RAVE, Medidata Zelta v1.0
Responsibilities
Create EDC system structure and workflows; Develop edit checks and user permissions; Create study-level documentation (specifications, test plans, training materials); Perform post-live changes under Change Control
Seniority
Mid-level, hands-on IC