About this role
Role Overview
- Oversight of monitoring effectiveness
- Implements various types of oversight encounters and activities
- Completes Sponsor Oversight Visit reports consistently
- Utilizes a risk-based approach to review critical to quality items
- Creates Study Specific Oversight Plans (SSOPs) for aligned trials
- Troubleshoots and uses alternative and innovative approaches to solve problems
- Builds relationships with investigators and site staff in region
Requirements
- Significant direct monitoring experience gained with a CRO or pharmaceutical company working on multinational clinical studies
- Previous CRO monitoring oversight experience and experience with oversight visits required
- Lead CRA experience required
- Experience in all study phases of clinical research (Phase I-III)
- Previous audit and regulatory inspection experience preferred
- Ability to travel; moderate travel
Benefits
- Health insurance
- Competitive salary
- Flexible working hours
- Professional development opportunities