EDC Developer, Zelta v2.0 Certified (Full-time 6-month contract)

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. We look forward to welcoming your application.