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 DeliveryLead 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 risksFacilitate periodic risk review meetings and drive proactive risk identification and mitigationProvide expert guidance on site risk levels, study health, and performance trendsDefine and implement study-specific monitoring strategies, including risk-based monitoring approaches such as targeted SDV or centralized monitoringRisk Oversight & ReportingDocument, communicate, and escalate risks to leadership as appropriateTrack, trend, and report Key Risk Indicators (KRIs) to support data-driven decision-makingPartner with internal teams and external vendors to manage risks, mitigations, and issue resolution timelinesEnsure CROs and service providers adhere to RBQM processes and expectationsSupport or lead program-level RBQM activities and escalationsGovernance, Compliance & Continuous ImprovementServe as a subject matter expert (SME) for RBQM across the organizationEnsure adherence to SOPs, work instructions, and regulatory requirementsContribute to ongoing enhancement of RBQM processes and toolsChampion a culture of quality, compliance, and continuous improvement
