About The Role

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
Zelta v2.0 experience is essential
Graduate or bachelor’s degree in Life Sciences (or Pharma or related health discipline) from an accredited university or college
Prior experience in EDC system creation and Edit Check programming 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, CDASH Certification preferred

When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world. You’ll join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.

We are diverse in many ways, yet our values unite us. Our values are how we work, not words on a wall. If they sound like you, you will feel at home here.

Quality: we hold ourselves to the standard patients deserve.
Integrity and trust: we do the right thing, especially when it is hard.
Drive and passion: we care about the outcome, because someone is waiting on it.
Agility and responsiveness: we move quickly, because patients cannot wait.
Belonging: everyone is welcome, and every voice counts.
Collaborative partnerships: we go further by going together.