Risk and Central Monitoring Associate Manager

Worldwide Clinical Trials · via Tech Sales Jobs

💰 $65,500 - $130,500/yr 🌎 Remote 📍 Remote, California ⌛ Posted 2 days ago

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

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

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