Operational Risk Manager

Key Responsibilities: Lead embedding and adoption of the end-to-end RBQM model within and across clinical study teams. Partner with cross-functional leads to develop and implement risk management strategies across therapeutic areas/programs. Facilitate Risk Assessment and Mitigation Planning (RAMP) meetings; prepare, review, and update RAMP documentation throughout the study lifecycle. Guide cross-functional teams in identifying critical data/processes, defining relevant Key Risk Indicators (KRIs), and establishing effective risk controls and response plans. Ensure alignment of risk discussions with study plans and global monitoring strategies. Coach and influence teams in risk mindset, methodology, and process maturity while fostering organizational capabilities. Analyze quality metrics/data and risk signals across study, regional, and site levels to drive continuous improvement and early intervention. Monitor risk mitigation execution, track issue trends, and ensure proper documentation, escalation, and communication of risks/issues. Support inspection readiness, audit response, and regulatory compliance, in collaboration with Clinical Process Compliance and Quality Assurance. Lead and contribute to RBQM process optimization, knowledge sharing, and best practice dissemination across studies and therapeutic areas.

Qualifications: Bachelor's degree in life sciences, risk-based, or related discipline; advanced degree preferred. Minimum of 10 years' comprehensive experience in clinical operations, with proven expertise in risk management, RBQM, or quality management. Excellent working knowledge of risk management methodologies (including risk identification, assessment, mitigation, and documentation).Demonstrated ability to influence cross-functional teams, senior management, and drive change management initiatives. Deep understanding of ICH/GCP, regulatory standards, and clinical trial processes. Strong analytical, critical thinking, and problem-solving skills; proficiency with data analysis/visualization tools. Exceptional communication, documentation, and interpersonal skills. Proven ability to lead in a dynamic global environment with complex, multi-jurisdictional studies. This is a hybrid based role working onsite T-TH. Candidates must be local to Lake County, IL; Irvine, CA or Florham Park, NJ and work onsite 3 days per week. Compensation Range:$ 124500 - 236500 USD