Risk Manager; RBQM & Monitoring - Remote: orCanada

Central Risk Manager (RBQM & Central Monitoring) – Remote:
United States or Canada

A highly visible opportunity for an experienced Central Risk Manager to serve as a subject matter expert in Risk‑Based Quality Management (RBQM), Risk‑Based Monitoring (RBM), and Central Monitoring across complex global clinical trials. The role focuses on strategy rather than execution, requiring strong business acumen, exceptional communication, and a consultative approach.

• Serve as a recognized RBQM and Centralized Monitoring subject matter expert across global clinical programs
• Influence study quality strategy from protocol review through study execution
• Partner directly with sponsors and senior stakeholders to develop and execute monitoring approaches
• Shape risk‑based monitoring strategies that impact study quality, efficiency, resource utilization, and patient safety
• Operate in a highly consultative role with significant visibility and organizational influence
• Leverage advanced analytics and centralized monitoring methodologies to drive proactive risk identification and mitigation
• Collaborate with experienced cross‑functional clinical research professionals
• Work at the forefront of evolving RBQM methodologies, technology platforms, data analytics, and emerging innovations within clinical research
• Opportunity to mentor colleagues and help drive continuous improvement across programs and teams

• Review study protocols to identify critical data, processes, risks, and quality considerations
• Lead and facilitate protocol execution risk assessments across cross‑functional teams
• Develop and refine Risk‑Based Monitoring (RBM) and Risk‑Based Quality Management (RBQM) strategies
• Draft and support Risk Assessment Categorization Tools (RACTs) and associated risk management documentation
• Identify risk mitigation plans and ensure appropriate oversight throughout study execution

• Utilize centralized monitoring technologies and analytics platforms to support risk identification and oversight
• Leverage data‑driven insights to guide monitoring strategy decisions
• Ensure monitoring approaches remain aligned with evolving study risks and operational realities
• Recommend strategic adjustments to monitoring activities, resource allocation, and oversight plans when necessary
• Evaluate centralized statistical monitoring outputs and recommend appropriate actions
• Support adoption of innovative technologies and emerging approaches to risk management

• Present monitoring strategies, risk assessments, and recommendations to internal stakeholders and sponsors
• Clearly communicate complex risk concepts to diverse audiences
• Present recommendations with confidence while managing questions, challenges, and competing viewpoints
• Build credibility as a trusted advisor capable of influencing strategic decisions
• Facilitate collaborative discussions focused on quality, compliance, efficiency, and patient safety

• Collaborate with Clinical Operations, Data Management, Medical Monitoring, Safety, Quality, and other functional teams
• Provide guidance and mentorship regarding RBQM methodologies and monitoring strategies
• Ensure consistency across studies, programs, therapeutic areas, and sponsor engagements
• Escalate risks appropriately and proactively when quality, timeline, budget, or delivery concerns arise
• Support business development activities including strategy discussions, proposal development, and budget input as needed

• Bachelor's degree, RN, or equivalent combination of education, training, and clinical research experience
• Significant experience within clinical research, CRO, biotechnology, or pharmaceutical environments
• Deep expertise in Risk‑Based Quality Management (RBQM) methodologies
• Strong experience with Risk‑Based Monitoring (RBM) strategies and implementation
• Central Monitoring experience or exposure, including methodologies, technologies, and operational execution
• Demonstrated experience conducting…