EDC Developer, Zelta v2.0 Certified

🔥 0 minutes ago

🌐 Serbia, United States – 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, including structure, workflow, edit checks, and user roles and permissions • Build EDC applications based on CDASH data standards, study protocols, and standard eCRF templates • Implement applicable functionality such as randomisation, ePRO, IMP Management, and Targeted SDV • Handle 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 change control • Work under the direction of the Director of Data Management with project-level oversight from the Project Data Manager

🎯 Requirements

• Zelta v2.0 experience is essential • Graduate or bachelor’s degree in Life Sciences, Pharma, or a related health discipline from an accredited university or college • Prior experience in EDC system creation and Edit Check programming is required • Effective communication skills • Cooperative and team-oriented approach • Self-motivation and ability to work independently • Proficiency in CDASH and SDTM data standards and their application to EDC system creation • CDASH Certification preferred

🏖️ Benefits

• Full-time 6-month contract • Opportunity to work remotely • Opportunity to work in any of the company's European locations • Collaborative and passionate team environment • Growth opportunities • Inclusive workplace where every voice counts

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