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Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Benefits
Comp & perks- Flexible working arrangements
- Professional development opportunities
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
protocol developmentregulatory writingdata reviewTMF audit readinessinvestigational product supply managementstudy closeoutbudget trackingCRO/vendor selectionclinical trial designGCP
Soft Skills
communicationorganizationalcollaboration
Certifications
advanced degree in life sciencesadvanced degree in healthcare
