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

📋 Description

• Develop EDC systems that include structure, workflows, edit checks, and user roles and permissions, adhering to CDASH data standards, study protocols, and standard eCRF templates.

• Enhance EDC functionality as needed, which may include features like randomization, ePRO, IMP management, and focused SDV.

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

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

• Implement 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 while receiving project-level 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, Pharmaceuticals, or a related health discipline from an accredited university or college is required.

• Prior experience in creating EDC systems and programming Edit Checks is necessary.

• Strong communication skills are essential.

• A collaborative and team-oriented mindset is important.

• Self-motivation and the capacity to work independently are required.

• Proficiency in data standards CDASH and SDTM and their implementation in EDC system development is necessary.

• CDASH Certification is preferred.