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WT
Risk and Central Monitoring Associate Manager
Posted 11 hours ago
About the role
- Risk and Central Monitoring Associate Manager overseeing RBQM and central monitoring for Worldwide Clinical Trials, a global clinical research organization. Supporting risk assessments, KRIs, QTLs, dashboards, and inspection readiness.
Responsibilities
- Lead and oversee Risk-Based Quality Management (RBQM) activities for assigned clinical studies
- Develop and maintain Central Monitoring Plans, ensuring appropriate approvals and alignment with study strategies
- Support creation and ongoing review of study risk assessments with cross-functional teams
- Facilitate identification, tracking, and monitoring of Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs)
- Perform centralized monitoring reviews to identify trends, outliers, signals, and potential risks, recommending actions to study teams
- Maintain central monitoring dashboards and support ongoing monitoring throughout the study lifecycle
- Deliver training and guidance to study teams on RBQM strategies, monitoring approaches, and risk management processes
- Contribute to inspection readiness, budget awareness, sponsor interactions, audits, and project-related meetings
- Collaborate with global teams and internal stakeholders and sponsors to support inspection-ready processes and clinical trial quality
Requirements
- BSc, RN, or an equivalent combination of education, skills, and experience
- At least 4 years of clinical research experience
- Minimum of 3 years of experience with Risk-Based Monitoring (RBM) and associated ICH/regulatory guidance
- Prior experience working as a Central Monitor or within a Central Monitoring function
- Strong understanding of RBQM principles, study risk assessments, centralized monitoring, KRIs, and QTLs
- Ability to analyze complex data, identify trends and risks, and apply critical thinking to problem-solving and issue resolution
- Experience collaborating across functions and working effectively within global project teams
- Strong communication, presentation, planning, and organizational skills
- Proficiency in English
- Strong proficiency with Microsoft Office and clinical technology systems
Benefits
- Competitive benefits package depending on location
- Inclusive and equitable workplace
- Transparent compensation and pay equity
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