Risk Management Lead

Accountabilities: Review study specifications, clinical protocols, test strategies, and study deliverables to verify that critical functionality has been appropriately designed, developed, tested, and validated. Lead and enhance risk assessment activities throughout the study lifecycle, working with cross-functional teams to identify emerging risks and establish effective mitigation strategies. Develop, maintain, and improve risk management frameworks, policies, procedures, and controls for customer support and operational delivery. Identify and evaluate operational, service delivery, compliance, data privacy, information security, and customer experience risks. Maintain risk registers and mitigation plans, monitor Key Risk Indicators (KRIs), and recommend corrective or preventive actions. Lead root cause analysis for major customer escalations, recurring issues, critical incidents, and service disruptions. Coordinate responses to high-severity customer-impacting events, ensuring timely resolution, effective communication, and appropriate follow-up. Partner with support and operations leaders to implement preventive measures, improve workflows, and strengthen service reliability and quality. Ensure operational activities align with internal policies, data privacy requirements, industry regulations, and applicable quality and compliance standards. Track remediation activities through completion, document lessons learned, and verify that mitigation plans are implemented effectively. Prepare executive-level risk reports, dashboards, and recommendations, communicating risk trends, mitigation progress, and service performance metrics to leadership. Collaborate with cross-functional stakeholders on emerging business risks, strategic initiatives, and impact assessments to support informed decision-making. Requirements: At least 5 years of experience in Customer Support, Operations, Risk Management, Quality, Compliance, or a related function. Mandatory: Recent, hands-on experience with production IRT/RTSM systems in the clinical trials industry. Candidates must demonstrate practical knowledge of the end-to-end study lifecycle, randomization, clinical supply and inventory management, test strategies, and testing approaches. Demonstrated experience managing customer-impacting risks, critical issues, and operational incidents within validated, regulated clinical trial technology environments. Candidates without substantive IRT/RTSM experience do not meet the minimum requirements. Experience assessing and managing operational risks in customer-facing organizations, including incident response, escalation management, and service improvement. A solid understanding of clinical trial operations, IRT/RTSM workflows, system controls, integrations, and applicable regulatory requirements. A bachelor's degree in Business, Operations, Risk Management, Information Technology, or a related discipline. Strong knowledge of Enterprise Risk Management (ERM), Customer Support Operations, Service Level Agreement (SLA) management, and Business Continuity Planning. Practical experience in root cause analysis, quality assurance, compliance, process optimization, and corrective and preventive action management. Ability to analyze operational metrics, KPIs, and KRIs and translate findings into clear reports, dashboards, and actionable recommendations. Awareness of data privacy and information security principles in regulated environments. Strong stakeholder management, communication, analytical thinking, and problem-solving skills, with the ability to provide hands-on leadership and strategic guidance. Experience in SaaS, pharmaceuticals, healthcare, life sciences, technology, or other regulated industries is preferred. Benefits: Remote working arrangement from India. Full-time opportunity focused on risk management within clinical trial technology and customer support operations. Opportunity to contribute to the reliability and quality of systems that support clinical trial execution. Cross-functional collaboration with Customer Support, Operations, Engineering, and other specialist teams. Scope to influence risk management practices, incident response, and continuous improvement initiatives. Opportunity to apply and expand expertise in regulated technology environments, operational risk, and clinical trial systems.