EDC Developer – Medidata RAVE, Zelta v1.0

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

📋 Description

• Develop EDC systems encompassing structure, workflow, edit checks, and user roles and permissions in accordance with CDASH, study protocols, and standard eCRF templates.

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

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

• Generate study-level EDC system documentation, which includes specifications, test plans, and study-specific training materials.

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

• Collaborate under the guidance of the Director of Data Management, receiving project-level oversight from the Project Data Manager.

⛳️ Requirements

• Experience with Medidata RAVE and Zelta v1.0 is required.

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

• Previous experience in EDC system development and Edit Check programming is mandatory.

• Strong communication skills are necessary.

• A collaborative and team-oriented mindset is expected.

• Self-motivation and the ability to work autonomously are crucial.

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

• CDASH Certification is preferred.

🏝️ Benefits

• Employees have the flexibility to work remotely.

• A collaborative team environment is fostered.

• Opportunities for professional growth are available.

• A diverse and inclusive workplace is promoted.

• An opportunity to positively impact patients' lives is provided.