EDC Developer – Medidata RAVE, Zelta v1.0

This is a fully remote position, open to applicants in New Zealand.

📋 Description

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

• Construct systems adhering to CDASH data standards, study protocols, and standardized eCRF templates.

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

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

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

• Carry out 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 supervision from the Project Data Manager.

⛳️ Requirements

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

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

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

• Strong communication skills are necessary.

• A collaborative and team-oriented mindset is important.

• Self-driven with the ability to work autonomously is required.

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

• CDASH Certification is preferred.

🏝️ Benefits

• Employment is full-time.

• Remote work options are available.

• Opportunity to contribute to safe and effective pharmaceutical treatments for patients.

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

• Work in a diverse and inclusive environment where every opinion matters.

• Opportunities for personal growth and significant contribution are available.