Risk Management Lead

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

Originally posted on Himalayas