EDC Developer, Zelta v2.0 Certified

This is a fully remote position, open to applicants in Serbia, +1 more country.

📋 Description

• Develop EDC systems encompassing structure, workflow, edit checks, and user roles along with permissions.

• Construct systems in alignment with CDASH data standards, study protocols, and standard eCRF templates.

• Execute relevant functionalities such as randomization, ePRO, IMP Management, and Targeted SDV.

• Manage ePRO licensing, validation, and translation as necessary.

• Produce study-level EDC documentation, which includes specifications, test plans, and training materials specific to the study.

• Conduct post-live modifications to EDC systems and related reporting applications in accordance with the Change Control process.

• Operate under the guidance of the Director of Data Management while receiving project-level supervision from the Project Data Manager.

⛳️ Requirements

• Experience with Zelta v2.0 is crucial.

• A graduate or bachelor’s degree in Life Sciences (or Pharma or a related health discipline) from an accredited institution is required.

• Prior experience in developing EDC systems and programming Edit Checks is essential.

• Strong communication skills are necessary.

• A collaborative and team-oriented mindset is vital.

• Self-motivation and the capability to work independently are important.

• Knowledge of data standards (CDASH & SDTM) and their application in EDC system development is required.

• CDASH Certification is preferred.

🏝️ Benefits

• Full-time contract for 6 months.

• Option for remote work.

• Opportunity to collaborate across various European locations.

• Join a team of experts in clinical research, pharmacovigilance, and quality consulting.

• Work in a diverse and inclusive environment where every voice is valued.