Risk Manager; RBQM & Monitoring

Job Title

Central Risk Manager (RBQM & Central Monitoring)

Remote – United States or Canada

• Serve as a subject matter expert in Risk-Based Quality Management (RBQM), Risk-Based Monitoring (RBM), and Central Monitoring across complex global clinical trials.
• Assess study protocols, identify critical risks, and develop monitoring strategies to support and improve study quality.
• Conduct and lead protocol execution risk assessments with cross‑functional teams.
• Draft Risk Assessment Categorization Tools (RACTs) and associated risk‑management documentation.
• Utilize centralized monitoring technologies and analytics platforms to support risk identification and oversight.
• Advise on and recommend strategic adjustments to monitoring activities, resource allocation, and oversight plans when necessary.
• Present monitoring strategies, risk assessments, and recommendations to internal stakeholders and sponsors.
• Provide guidance and mentorship regarding RBQM methodologies and monitoring strategies to cross‑functional teams.
• 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.

• Recognized 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.
• Opportunity to mentor colleagues and help drive continuous improvement across programs and teams.

• 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 study‑level risk assessments and developing monitoring strategies.
• Strong understanding of ICH‑GCP and applicable regulatory requirements.
• Excellent verbal and written communication skills with strong English proficiency.
• Proven ability to present complex concepts clearly and persuasively.
• Strong stakeholder management, negotiation, and influencing capabilities.
• Exceptional critical thinking, analytical, and problem‑solving skills.
• Ability to work independently within fast‑paced, evolving environments.

• Risk Manager
• RBQM Lead
• Clinical Trial Manager (CTM)
• Central Monitoring Lead
• Project Lead / Clinical Project Manager
• Data Management Lead
• Central Monitoring professional with significant strategic ownership

• Familiarity with central monitoring and analytics platforms such as CluePoints, Spotfire, Tableau, Power BI, or comparable technologies.
• Understanding of how these tools support RBQM and centralized monitoring.
• Risk identification methodologies, data review workflows, and analytics‑driven decision making.
• Data visualization techniques, trend analysis, outlier detection, data integrity assessment, statistical monitoring concepts, and risk signal detection methodologies.
• Advanced Microsoft Excel skills, including pivot tables, filtering, sorting, and data analysis.
• Knowledge of quality risk management principles and RACT tools.
• Interest in emerging technologies, AI, and innovation within clinical research.

• St…