Sr. Clinical Risk Manager

We are seeking a highly experienced Senior Clinical Risk Manager to lead the execution of our Risk-Based Quality Management (RBQM) strategy across a portfolio of complex clinical trials. In this role, you will partner with cross-functional teams, Clinical Research Organizations (CROs), and key stakeholders to proactively identify, assess, and mitigate risks—ensuring high-quality study delivery and compliance with global regulatory requirements.

This is a highly visible role that requires strong leadership, strategic thinking, and deep RBQM expertise to support study and program-level success.

RBQM Execution & Study Delivery

• Lead the development and management of study-level risk assessments, including Risk Assessment Categorization Tools (RACTs) and integrated Quality Risk Management Plans (iQRMPs)
• Maintain risk logs and ensure accurate, real-time tracking of study risks
• Facilitate periodic risk review meetings and drive proactive risk identification and mitigation
• Provide expert guidance on site risk levels, study health, and performance trends
• Define and implement study-specific monitoring strategies, including risk-based monitoring approaches such as targeted SDV or centralized monitoring

Risk Oversight & Reporting

• Document, communicate, and escalate risks to leadership as appropriate
• Track, trend, and report Key Risk Indicators (KRIs) to support data-driven decision-making
• Partner with internal teams and external vendors to manage risks, mitigations, and issue resolution timelines
• Ensure CROs and service providers adhere to RBQM processes and expectations
• Support or lead program-level RBQM activities and escalations

Governance, Compliance & Continuous Improvement

• Serve as a subject matter expert (SME) for RBQM across the organization
• Ensure adherence to SOPs, work instructions, and regulatory requirements
• Contribute to ongoing enhancement of RBQM processes and tools
• Champion a culture of quality, compliance, and continuous improvement