Risk and Central Monitoring Associate Manager
About The Position
Help drive quality and oversight across clinical trials by supporting risk management and central monitoring activities that are critical to study success. In this role, you'll work with cross-functional teams to identify, assess, and monitor study risks while helping ensure trials are conducted in accordance with ICH GCP guidelines. You'll play an important role in advancing Risk-Based Quality Management (RBQM) strategies, supporting study teams with risk assessments, centralized monitoring activities, and data-driven insights that help maintain quality throughout the clinical trial lifecycle. Working closely with internal stakeholders and sponsors, you'll contribute to consistent, inspection-ready processes while helping teams focus on what matters most: delivering high-quality clinical research that supports better outcomes for patients.
Requirements
- BSc, RN, or an equivalent combination of education, skills, and experience.
- At least 4 years of clinical research experience, including a 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.
- Demonstrated 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 and strong proficiency with Microsoft Office and clinical technology systems.
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 the creation and ongoing review of study risk assessments, partnering with cross-functional teams to identify and evaluate risks.
- Facilitate the 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 activities throughout the study lifecycle.
- Deliver training and guidance to study teams on RBQM strategies, monitoring approaches, and risk management processes.
- Contribute to inspection readiness activities, budget awareness, sponsor interactions, audits, and other project-related meetings.
Benefits
- Competitive benefits package
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Associate degree
