Tech Stack
Google Cloud Platform
About the role
- Draft sections of protocols, CRFs, training materials, and data review plans
- Oversee data review and TMF audit readiness
- Support study closeout, issue resolution, and lifecycle budget tracking
- Contribute to Managed Access Program coordination and compliance
- Coordinate CRO/vendor selection and performance
- Lead cross-functional collaboration with data management, drug supply, and more
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
- Health insurance
- Flexible working hours
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
protocol developmentregulatory writingdata reviewbudget trackingstudy closeoutclinical trial designGCPphase IV trialsPASS trialsNIS trials
Soft skills
cross-functional collaborationissue resolutioncoordination
Certifications
advanced degree in life sciencesadvanced degree in healthcare