
EDC Developer, Zelta v2.0 Certified
Posted Aug 25

Posted Aug 25
This is a fully remote position, open to applicants in Serbia.
• Develop EDC systems encompassing structure, workflow, edit checks, and user roles and permissions in accordance with CDASH, study protocols, and standard eCRF templates.
• Execute relevant functionalities such as randomization, ePRO, IMP Management, and Targeted SDV.
• Oversee ePRO licensing, validation, and translation as necessary.
• Generate study-level EDC documentation, including specifications, test plans, and tailored training materials for the study.
• Conduct post-live modifications to EDC systems and related reporting applications following the Change Control process.
• Operate under the guidance of the Director of Data Management, while receiving project-level oversight from the Project Data Manager.
• Experience with Zelta v2.0 is essential.
• A graduate or bachelor’s degree in Life Sciences, Pharma, or a related health discipline from an accredited institution is required.
• Previous experience in the creation of EDC systems and Edit Check programming is necessary.
• Strong communication skills are a must.
• A cooperative and team-oriented mindset is essential.
• Self-motivation and the ability to work independently are key attributes.
• Proficiency in data standards (CDASH and SDTM) and their application in EDC system development is needed.
• CDASH Certification is preferred.
• Full-time 6-month contract.
• Availability for remote work.
• Opportunity to work across various European locations.
• Collaborative team environment.
• Opportunities for growth and development.
• A diverse and inclusive workplace.
• Work that contributes to safer pharmaceutical treatments for patients.
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