EDC Developer, Zelta v2.0 Certified

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

📋 Description

• Design EDC systems encompassing structure, workflow, edit checks, and user roles and permissions in alignment with CDASH, study protocol, and standard eCRF templates.

• Create additional EDC functionalities such as randomization, ePRO, IMP Management, and Targeted SDV.

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

• Develop documentation for study-level EDC systems, including specifications, test plans, and training materials tailored to specific studies.

• Execute post-live modifications to EDC systems and relevant reporting applications following the Change Control process.

• Operate under the guidance of the Director of Data Management with project-level oversight provided by the Project Data Manager.

⛳️ Requirements

• Experience with Zelta v2.0 is crucial.

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

• Prior experience in the development of EDC systems and Edit Check programming is mandatory.

• Strong communication skills are essential.

• A collaborative and team-oriented mindset is required.

• Self-motivated individuals with the ability to work autonomously are preferred.

• Proficiency in data standards (CDASH and SDTM) and their application in EDC system development is necessary.

• CDASH Certification is advantageous.

🏝️ Benefits

• Full-time contract for 6 months.

• Remote work options available.

• Chance to collaborate with a dedicated and innovative team of professionals in clinical research, pharmacovigilance, and quality consulting.

• A diverse and inclusive workplace where each voice is valued.