EDC Developer: Build Safe, Scalable Clinical Data Systems

Ergomed; Województwo mazowieckie; On-site; PLN 306,000 - 394,000; Full time

Job summary

Ergomed Group is seeking an EDC Developer to join the Data Management team. You will build the EDC application for complex projects under supervision, implementing structure, workflows, and user roles per data standards and study protocols.

The role requires experience in EDC system creation, Edit Check programming, and CDASH/SDTM familiarity. You will collaborate with cross-functional teams to ensure data quality and regulatory compliance across trials.

Qualifications

• Prior experience in EDC system creation and Edit Check programming is a must.
• Graduate or bachelor’s degree in Life Sciences (or Pharma or related health discipline) from an accredited university or college.
• Proficiency in data standards (CDASH & SDTM) and application to EDC system creation, CDASH Certification preferred.
• Effective communication skills.
• Cooperative and team-oriented approach.
• Self-motivation and ability to work independently.

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; Targeted SDV; any other additional EDC functionality.
• Creates all study level documentation related to EDC System, including Specifications, Test Plans, Study training materials.
• Performs post-live changes to EDC system and applicable reporting applications under Change Control process.

Skills

EDC development

Edit checks

CDASH/SDTM

Communication

Teamwork

Self-motivation

CDASH Certification

Education

Bachelor's degree in Life Sciences/Pharma or related health discipline

Job description

Ergomed Group is seeking an EDC Developer to join the Data Management team. You will build the EDC application for complex projects under supervision, implementing structure, workflows, and user roles per data standards and study protocols.

The role requires experience in EDC system creation, Edit Check programming, and CDASH/SDTM familiarity. You will collaborate with cross-functional teams to ensure data quality and regulatory compliance across trials.