EDC Developer – Medidata RAVE, Zelta v1.0

🔥 14 hours ago

🌐 New Zealand, Poland – Remote

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⏰ Full Time

🟡 Mid-level

🟠 Senior

🖥 Software Engineer

👻 Ghost score 16%

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Logo of ERGOMED

ERGOMED

1001 - 5000 employees

Founded 1997

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ERGOMED is a global group providing specialized services to the biotechnology and pharmaceutical industries. It operates under different service lines, including Ergomed Clinical Research, PrimeVigilance, and ADAMAS Consulting, and is dedicated to providing full-service clinical research organization (CRO) capabilities. Focused on oncology, rare diseases, and complex trials, it also offers end-to-end pharmacovigilance and medical information services, as well as comprehensive GxP audits. Ergomed is committed to supporting drug development with a global presence in around 100 countries.

📋 Description

• Create EDC systems in terms of structure, workflow, edit checks, and user roles and permissions based on CDASH, study protocol, and standard eCRF templates • Build applicable additional EDC functionality, including randomisation, ePRO, IMP Management, and Targeted SDV • Manage ePRO licensing, validation, and translation where applicable • Create study-level EDC documentation, including specifications, test plans, and study-specific training materials • Perform post-live changes to EDC systems and applicable reporting applications under the Change Control process • Work under the direction of the Director of Data Management with project-level oversight from the Project Data Manager

🎯 Requirements

• Medidata RAVE and Zelta v1.0 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

🏖️ Benefits

• Employees can work remotely • Collaborative team environment • Opportunities for growth and professional development • Diverse and inclusive workplace • Passionate team of experts in clinical research, pharmacovigilance, and quality consulting

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