The Risk Management Lead identifies, assesses, and mitigates operational risks within clinical trial technology environments to ensure service reliability and compliance. This role involves leading root cause analyses, managing customer escalations, and developing risk management frameworks to drive continuous improvement.
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.
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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
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