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 protocol, and standardized eCRF templates.

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

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

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

• 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 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 (or a related health discipline such as Pharma) from an accredited university or college is required.

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

• Strong communication skills are necessary.

• A cooperative and team-oriented mindset is important.

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

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

• CDASH Certification is preferred.