
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.
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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.
• 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, Targeted SDV, and other non-core EDC functionality • Create study-level EDC documentation, including specifications, test plans, and study-specific training materials • Solve mid-level challenges and address sponsor requests and concerns • 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
• Graduate or bachelor’s degree in Life Sciences, Pharma, or related health discipline from an accredited university or college • Zelta v2.0 experience is essential • Prior experience in EDC system creation and Edit Check programming (Zelta, Medidata) 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 their application to EDC system creation • CDASH Certification preferred
• Remote work available • Full-time 6 month contract • Collaborative team environment • Opportunities for personal growth • Diverse and inclusive workplace • Work contributing to safer pharmaceutical treatments for patients • Collaborative partnerships across countries, cultures, and time zones
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