EDC Developer: Medidata RAVE & Zelta Expert

Ergomed; United States; Remote; USD 110,000 - 150,000; Full time

Job summary

Ergomed is seeking an EDC Developer to build the EDC application for complex clinical projects. You will work under the Director of Data Management with project-level oversight, shaping EDC structure, workflow, and user access.

The role requires experience in EDC systems, edit checks, CDASH/SDTM standards, and proficiency with Medidata RAVE and Zelta v1.0. Strong communication and independent work skills are essential.

Qualifications

• Must have a degree in Life Sciences, Pharmacy or related health discipline.
• Experience in EDC system creation and Edit Check programming is required.
• Proficiency in CDASH/SDTM data standards and CDASH certification preferred.
• Strong communication skills and ability to work both independently and in a team.

Responsibilities

• Creates EDC system structure, workflow, edit checks and user roles/permissions per CDASH and study protocol.
• Includes randomisation, ePRO, IMP management and targeted SDV.
• Develops all study-level EDC documentation: specifications, test plans, training materials.
• Performs post-live changes under Change Control and updates reporting tools as needed.
• Demonstrates experience with Medidata RAVE and Zelta v1.0.
• Communicates effectively and collaborates with project teams.

Skills

EDC system creation

Edit Check programming

CDASH & SDTM knowledge

CDASH Certification

Effective communication

Independent work

Team collaboration

Self-motivation

Education

Bachelor’s degree in Life Sciences/Pharma/health

Tools

Medidata RAVE

Zelta v1.0

Job description

Ergomed is seeking an EDC Developer to build the EDC application for complex clinical projects. You will work under the Director of Data Management with project-level oversight, shaping EDC structure, workflow, and user access.

The role requires experience in EDC systems, edit checks, CDASH/SDTM standards, and proficiency with Medidata RAVE and Zelta v1.0. Strong communication and independent work skills are essential.