Central Risk Manager (RBQM & Central Monitoring) - Remote: United States or Canada
$95,000–$175,700 year
RemoteUnited States or Canada
Job Summary
Review study protocols to identify critical data, processes, risks, and quality considerations, then 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 Risk Assessment Categorization Tools, and ensure appropriate oversight throughout study execution. Utilize centralized monitoring technologies and analytics platforms to support proactive risk identification, leveraging data-driven insights to guide monitoring strategy decisions and recommend strategic adjustments to resource allocation. Present monitoring strategies and risk assessments to internal stakeholders and sponsors, clearly communicating complex risk concepts while managing competing viewpoints. Collaborate with Clinical Operations, Data Management, and Medical teams to provide guidance on RBQM methodologies, escalate risks proactively, and support business development activities including strategy discussions and budget input.
Required Qualifications
- 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
Desired Qualifications
- Strong preference will be given to candidates who have operated in strategic or leadership-level roles such as: 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 & Analytics Platforms (CluePoints, Spotfire, Tableau, Power BI)
- Understanding of how these tools support RBQM and centralized monitoring
- Knowledge of risk identification methodologies
- Knowledge of data review workflows
- Knowledge of analytics-driven decision making
- Knowledge of data visualization techniques
- Knowledge of trend analysis
- Knowledge of outlier detection
- Knowledge of data integrity assessment
- Knowledge of statistical monitoring concepts
- Knowledge of risk signal detection methodologies
- Advanced Microsoft Excel skills, including pivot tables, filtering, sorting, and data analysis
- Understanding of quality risk management principles
- Familiarity with RACT tools and risk assessment frameworks
- Interest in emerging technologies, AI, and innovation within clinical research
- Strategic thinkers who can balance quality, risk, budget, and operational realities
- Confident communicators who can influence without direct authority
- Self-motivated professionals who thrive with autonomy
- Critical thinkers who challenge assumptions and identify better solutions
- Adaptable leaders comfortable navigating ambiguity and change
- Collaborative team players who support colleagues and contribute positively to team culture
- Curious professionals who embrace innovation and continuous learning
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