About the role
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