Key skills
Google Cloud PlatformGCPGoogle CloudRisk Management
About this role
Role Overview
- Develop processes, systems and standards for inspection readiness in clinical studies
- Manage internal quality processes for compliance with quality standards
- Drive implementation of the Quality Management System (QMS) Framework
- Lead development of study level quality risk management plans
- Integrate Clinical Compliance Management (CCM) into Study Execution Teams (SET)
Requirements
- Degree (BSc/MSc/Diploma) in scientific/medical/pharmaceutical discipline
- 10+ years of professional work experience in a Clinical Development/Research environment
- Extensive understanding of the clinical research and drug development lifecycle
- 3+ years of line management experience
- Thorough knowledge of ICH GCP, FDA GCP Regulations and EU clinical trials directive
Tech Stack
- Google Cloud Platform
Benefits
- Health insurance
- 401(k) plans
- Paid time off
- Flexible work arrangements
- Professional development