Key skills
Google Cloud PlatformGCPGoogle CloudCommunicationCollaboration
About this role
Role Overview
- Draft sections of protocols, CRFs, training materials, and data review plans
- Contribute to the development of safety updates, IBs, and regulatory submissions
- Oversee data review and TMF audit readiness
- Forecast/manage investigational product supply
- Support study closeout, issue resolution, and lifecycle budget tracking
- Coordinate CRO/vendor selection and performance
- Facilitate advisory boards (DMCs/Steering Committees) and serve as the site liaison
Requirements
- Advanced degree in life sciences or healthcare
- 2–5 years' global experience managing phase IV, PASS, PAES, or NIS trials
- Strong track record in protocol development, study startup, and regulatory writing (e.g. PSURs, DSURs, NDA/BLA reports)
- Deep understanding of GCP and clinical trial design
- Excellent communication, organizational, and collaboration skills
Tech Stack
- Google Cloud Platform
Benefits
- Flexible working arrangements
- Professional development opportunities