EDC Developer, Full Time, 6 Month Contract

🔥 0 minutes ago

🌐 Serbia, Romania – 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 for complex projects, including structure, workflow, edit checks, and user roles and permissions • Apply CDASH data standards, study protocols, and standard eCRF templates to EDC system creation • 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 the Change Control process • 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 related health discipline from an accredited university or college • Prior experience in EDC system creation and Edit Check programming • 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

• Remote work options • Collaborative and passionate team environment • Opportunities for growth and making a real difference to patients' lives • Diverse and inclusive workplace where every voice counts

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