endpointclinical - Risk Management Lead
Requirements
• 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. • Bachelor's degree in Business, Operations, Risk Management, Information Technology, or a related field. • 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
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.
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