Key skills
Google Cloud PlatformGCPGoogle CloudCommunicationCritical Thinking
About this role
Role Overview
- Collaborate on Study Quality Risk Assessment
- Develop and Author the Central Monitoring Plan
- Oversee Central Monitoring Execution
- Analyze and Interpret Data Trends
- Facilitate Study Team Decisions
- Document and Track Actions
- Act as Central Monitoring subject matter expert
- Provide Oversight of Contract Research Organization (CRO) Activities
- Drive Process Improvements
- Represent Central Monitoring in Initiatives
Requirements
- At least 7 years of relevant experience in the biotechnology/pharmaceutical industry
- Minimum of 1 year with direct Central Monitoring experience
- Strong analytical problem-solving and critical thinking abilities
- Working knowledge of the clinical drug development process, including ICH, GCP guidelines, and regulatory requirements
- Excellent written communication skills
- Proficiency in Microsoft Office applications, with advanced skills in Excel for data manipulation and reporting
Tech Stack
- Google Cloud Platform
Benefits
- Professional development opportunities
- Flexible work arrangements
- Health insurance
- Paid time off