EDC Developer (Full time 6 month contract)
Ergomed
•Remote
About The Position
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.
Requirements
- Graduate or bachelor’s degree in Life Sciences (or Pharma or related health discipline) from an accredited university or college
- Zelta v2.0 experience is essential
- Prior experience in EDC system creation and Edit Check programming (Zelta, Medidata) is a must
- Effective communication skills
- Cooperative and team-oriented approach
- Self-motivation and ability to work independently
- Proficiency in data standards (CDASH & SDTM) and application to EDC system creation
Nice To Haves
- CDASH Certification preferred
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
- Problem solver for mid-level challenges and able to address sponsor requests and concerns as applicable
- Performs post-live changes to EDC system and applicable reporting applications under Change Control process
Benefits
- Helping to bring safe and effective pharmaceutical treatment to patients around the world
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
Upload and Match Resume
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
