Risk Management Lead

13 hours, 3 minutes ago
Full-time
Lead
Customer and Technical Support
endpoint Clinical

endpoint Clinical

endpoint Clinical specializes in providing interactive response technology (IRT) systems that streamline clinical trial management for the life sciences industry, enabling study administrators to efficiently adjust parameters and manage clinical suppli...

Pharmaceuticals
501-1000
Founded 2009

Description

  • Review study specifications, protocols, test strategies, and deliverables to verify critical functionality is designed, tested, and operating effectively.
  • Develop and maintain risk management frameworks, policies, and procedures for Customer Support operations.
  • Conduct risk assessments across the study lifecycle and identify operational, service, compliance, data privacy, and customer experience risks.
  • Maintain risk registers, develop mitigation plans, monitor KRIs, and drive corrective actions.
  • Lead root cause analyses for major escalations, recurring issues, service incidents, and customer-impacting events.
  • Coordinate response efforts for high-severity customer escalations and track remediation actions through closure.
  • Partner with Support, Operations, Engineering, and other teams to implement preventive actions and continuous-improvement initiatives.
  • Ensure support workflows, tools, and customer interactions comply with operational best practices, company policies, privacy requirements, and industry regulations.
  • Prepare and present executive risk reports, dashboards, risk trends, mitigation updates, and service performance metrics.
  • Conduct risk and impact analyses for strategic initiatives and emerging business risks.

Requirements

  • 5+ years of experience in Customer Support, Operations, Risk Management, Quality, Compliance, or a related function.
  • Direct, recent, hands-on experience supporting or managing production clinical trial IRT/RTSM systems.
  • Practical expertise across the IRT/RTSM study lifecycle, including randomization, clinical supply and inventory management, test strategies, and testing approaches.
  • Experience managing customer-impacting risks and critical issues in validated, regulated environments.
  • Experience managing operational risks within customer-facing organizations.
  • Strong experience in incident management, escalation management, root cause analysis, and process improvement.
  • Advanced knowledge of clinical trial operations and end-to-end IRT/RTSM controls, integrations, risks, and regulatory requirements.
  • Knowledge of enterprise risk management, SLA management, quality assurance, compliance, business continuity planning, data privacy, and information security.
  • Experience with KPI/KRI reporting, analytics, and stakeholder management.
  • Bachelor's degree in Business, Operations, Risk Management, Information Technology, or a related field.
  • Experience in SaaS, Pharma, Healthcare, Technology, Life Sciences, or another regulated industry (preferred).

Interested in this position?

Apply directly on the company website

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