Clinical Operations

• Provide Clinical Quality oversight and support for clinical study teams
• Serve as the dedicated, single point of Quality contact for the client
• Partner with Operations to establish a consistent Quality culture across clinical trial studies or portfolios
• Participate in regular partnership-level and ad hoc team meetings
• Provide directions and recommendations for issue avoidance
• Maintain continuous awareness and periodically review QE, SSM, SB, sPIP, audit, and inspection activities
• Escalate appropriately to Client Quality, Quality Partner, Strategic Alliance Lead, bPL, PDL, or OD to minimize client impact and improve outcomes
• Enable and facilitate Quality Risk Management
• Prepare and analyze QA-related Key Quality Indicators for emerging trends and potential risks
• Promote compliance with client-specific quality-event, audit, and inspection-response requirements
• Incorporate quality insights into operational lessons learned and promote awareness across the portfolio
• Drive Partnership Governance support
• Co-chair Joint Quality Councils and contribute to other governance meetings
• Present quality metrics and trends and discuss potential resolutions with relevant stakeholders

Explore Compliance Manager, Clinical Quality Assurance Oversight at Thermo Fisher Scientific. Review requirements and application details.