Risk Management Lead

• Review study specifications, protocols, test strategies, and other study deliverables to confirm critical functionality is appropriately designed, built, tested, and functioning effectively
• Strengthen and improve risk assessments across the study lifecycle
• Conduct reviews, risk assessments, issue analysis, and mitigation follow-through while providing strategic guidance
• 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 risk registers 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
• Implement preventive actions and continuous improvement initiatives with support leaders
• Manage risks associated with support workflows, tools, and customer interactions
• Ensure adherence to operational delivery best practices, company policies, data privacy requirements, and industry regulations
• Drive quality improvement initiatives across delivery functions
• Lead risk assessments for critical incidents and customer-impacting events
• Coordinate response efforts during high-severity customer escalations
• Capture lessons learned and ensure mitigation plans are implemented
• Track remediation actions through closure
• Prepare executive-level risk reports, dashboards, and recommendations
• Present risk trends, mitigation efforts, and service performance metrics to leadership
• Address emerging business risks with cross-functional teams
• Conduct risk assessments and impact analyses for strategic initiatives

• 5+ years of experience in Customer Support, Operations, Risk Management, Quality, Compliance, or related functions
• 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
• 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
• Experience managing operational risks within customer-facing organizations
• Strong background in incident management, escalation management, and process improvement
• Experience 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