Manager, Risk Based Quality Management

About the role

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. CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations. We assist clinical research throughout the lifecycle of development, from drug concept to commercialization. CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms. For more information, visit www.ctifacts.com

Responsibilities

• 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
• Coordinate RBQM trial specific activities, and ensure trial team accountability
• Support routine centralized monitoring (KRI/QTL review) activities and risk review preparation and meetings
• Partner with Clinical Project Management, Data Management, Quality, Medical Monitoring, Biostatistics, and other functional teams to support RBQM execution
• Assist the Director, RBQM with strategic, operational, and client-facing initiatives
• Utilize RBQM platforms and systems (e.g., BI RBQM tools, CluePoints, Medidata) to support monitoring and documentation activities
• Contribute to process improvement initiatives related to RBQM execution, tools, and documentation