EDC Developer (Medidata RAVE and Zelta v1.0)

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

Qualifications :

• Medidata RAVE and Zelta v1.0 experience is essential
• Graduate or bachelors 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

Additional Information :

When you join Ergomed Group you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world. Youll 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.

Remote Work :

Yes

Employment Type :

Full-time

Department / Functional Area: Data Management
Experience: years
Vacancy: 1