The Risk Management - Lead is responsible for identifying, assessing, monitoring, and mitigating risks that impact customer support operations, service delivery, customer satisfaction, compliance, and business continuity within a clinical trial technology environment. This role partners closely with Customer Support, Operations, Engineering to proactively manage operational risks, improve service reliability, and drive a culture of continuous improvement across Interactive Response Technology (IRT) and Randomization and Trial Supply Management (RTSM) solutions. The Risk Management - Lead is responsible for identifying, assessing, monitoring, and mitigating risks that impact customer support operations, service delivery, customer satisfaction, compliance, and business continuity within a clinical trial technology environment. This role partners closely with Customer Support, Operations, Engineering to proactively manage operational risks, improve service reliability, and drive a culture of continuous improvement across Interactive Response Technology (IRT) and Randomization and Trial Supply Management (RTSM) solutions. Responsibilities - Review study specifications, protocols, test strategies, and other study deliverables to confirm that critical functionality has been appropriately designed, built, tested, and is functioning effectively. - Partner with all relevant groups to strengthen, enhance, and drive more effective risk assessments across the study lifecycle. - Serve as a hands-on lead, directly conducting reviews, risk assessments, issue analysis, and mitigation follow-through, while also providing strategic guidance and advice. - Develop and maintain risk management frameworks, policies, and procedures for Customer Support operations. - Identify operational, service, compliance, data privacy, and customer experience risks. - Provide expert input to support risk register and mitigation plans. - Monitor Key Risk Indicators (KRIs) and recommend corrective actions. - Lead root cause analysis for major customer escalations, recurring issues, and service incidents. - Collaborate with support leaders to implement preventive actions and continuous improvement initiatives. - Ensure risks associated with support workflows, tools, and customer interactions are effectively managed. - Ensure adherence to best practices related to Operational Delivery, company policies, data privacy requirements, and industry regulations. - Drive quality improvement initiatives across delivery functions where applicable. - Lead risk assessments related to critical incidents and customer-impacting events. - Coordinate response efforts during high-severity customer escalations. - Ensure lessons learned are captured and mitigation plans are implemented. - Track remediation actions through closure. - Prepare executive-level risk reports, dashboards, and recommendations. - Present key risk trends, mitigation efforts, and service performance metrics to leadership. - Partner with cross-functional teams to address emerging business risks. - Support strategic initiatives by conducting risk assessments and impact analyses. Experience - 5+ years of experience in Customer Support, Operations, Risk Management, Quality, Compliance, or related functions. - Mandatory – IRT/RTSM Experience: Direct, recent, and hands-on experience in the clinical trials industry supporting or managing production Interactive Response Technology (IRT)/Randomization and Trial Supply Management (RTSM) systems is required. Candidates must demonstrate practical expertise across the IRT/RTSM study lifecycle, randomization, clinical supply and inventory management, test strategy and testing approaches. Experience managing customer-impacting risks and critical issues within validated, regulated environments is essential. Candidates without substantive IRT/RTSM experience will not meet the minimum requirements for this position. - Experience managing operational risks within customer-facing organizations. - Strong background in incident management, escalation management, and process improvement. - Experience working in SaaS, Pharma, Healthcare, Technology, Life Sciences, or similar regulated industries is preferred. Education Bachelor's degree in Business, Operations, Risk Management, Information Technology, or a related field. Required Skills - Enterprise Risk Management (ERM) - Customer Support Operations - Advanced, applied knowledge of clinical trial operations and end-to-end IRT/RTSM processes, controls, integrations, risks, and regulatory requirements - Incident & Escalation Management - Root Cause Analysis (RCA) - SLA Management - Quality Assurance & Compliance - Business Continuity Planning - Data Privacy & Information Security Awareness - Process Improvement and Optimization - KPI/KRI Reporting and Analytics - Stakeholder Management

Risk Management Lead

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