EDC Developer (Medidata RAVE and Zelta v1.0)

The EDC Developer within the ERGOMED Data Management (DM) department is responsible for all tasks linked to the building of the EDC application for complex projects. The EDC Developer represents a position under direction of the Director of Data Management, with oversight by the Project Data Manager on a project level.

ROLE AND RESPONSIBILITIES

• Creates EDC system in terms of structure, workflow, edit checks and user roles & permissions; based on data standards (CDASH), study protocol and standard eCRF templates. Including, where applicable:
• Randomisation
• ePRO (including licensing, validation & translation)
• IMP Management
• Targeted SDV
• Any other additional (non-core) EDC functionality

Creates all study level documentation related to EDC System, including, but not limited to:

• Specifications
• Test Plans
• Study specific training materials
• Performs post-live changes to EDC system and applicable reporting applications under Change Control process