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Manager, Risk Based Quality Management
CTI Clinical Trial and Consulting Services
Remote, USA
Full-time
Entry · 2+ years experience
Remote
Discovered Today
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Role Overview
Supports the execution, operationalization, sustainability, and continuous improvement of CTI’s Risk-Based Quality Management framework across the clinical trial portfolio. This role supports the Director, RBQM by coordinating Integrated Quality and Risk Management Plan activities, facilitating cross-functional risk management processes, supporting CtQ identification, coordinating RACT/RMP/IDRP activities, and maintaining RBQM documentation and follow-up accountability. This position provides operational infrastructure to help ensure consistent RBQM execution, proactive risk oversight, risk review discipline, documentation governance, and cross-functional alignment across studies. This is an entry to mid-level role focused on operational execution, working under the guidance of Clinical Project Management and RBQM leadership.
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Job Summary
Supports the execution, operationalization, sustainability, and continuous improvement of CTI’s Risk-Based Quality Management framework across the clinical trial portfolio. This role supports the Director, RBQM by coordinating Integrated Quality and Risk Management Plan activities, facilitating cross-functional risk management processes, supporting CtQ identification, coordinating RACT/RMP/IDRP activities, and maintaining RBQM documentation and follow-up accountability. This position provides operational infrastructure to help ensure consistent RBQM execution, proactive risk oversight, risk review discipline, documentation governance, and cross-functional alignment across studies. This is an entry to mid-level role focused on operational execution, working under the guidance of Clinical Project Management and RBQM leadership.
What You'll Do
Coordinate development and maintenance of Integrated Quality and Risk Management Plans (IQRMPs)
Support and coordinate RACT, RMP, and IDRP activities, including protocol review and assessment
Facilitate cross-functional risk review meetings and ensure action items are tracked to completion
Maintain RBQM documentation, trackers, logs, templates, and SharePoint resources
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