EDC Developer (Zelta v2.0) Data Management Expert

Ergomed; Warszawa; On-site; PLN 120,000 - 180,000; Full time

Job summary

Ergomed Group is seeking an EDC Developer to join the Data Management team to build and maintain the EDC application for complex projects. You will report to the Director of Data Management with project-level oversight.

The role involves creating EDC structures, workflows, edit checks, and user roles based on CDASH, study protocol, and standard eCRF templates. It also covers randomisation, ePRO, IMP management, and SDV, plus study documentation and post-live changes.

Qualifications

• Zelta v2.0 experience is essential.
• Graduate or bachelor’s degree in Life Sciences (or Pharma or related health discipline).
• Prior experience in EDC system creation and Edit Check programming.
• Cooperative and team-oriented approach.
• Self-motivation and ability to work independently.
• Proficiency in data standards (CDASH & SDTM) and application to EDC system creation, 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.
• Includes randomisation, ePRO (licensing, validation & translation), IMP Management, and targeted SDV.
• Other 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.

Skills

EDC development

Edit Check programming

CDASH & SDTM

Independent work

Team collaboration

Life Sciences knowledge

Education

Bachelor’s degree in Life Sciences or related field

Tools

Zelta v2.0

Job description

Ergomed Group is seeking an EDC Developer to join the Data Management team to build and maintain the EDC application for complex projects. You will report to the Director of Data Management with project-level oversight.

The role involves creating EDC structures, workflows, edit checks, and user roles based on CDASH, study protocol, and standard eCRF templates. It also covers randomisation, ePRO, IMP management, and SDV, plus study documentation and post-live changes.