RBQM Operations Lead

CTI Clinical Trial Services Inc; Cincinnati (OH); Hybrid; USD 65,000 - 90,000; Full time

Benefits offered by this job

Hybrid work from home

Health benefits

Paid parental leave

Job summary

CTI Clinical Trial Services Inc. is seeking an entry- to mid-level RBQM Operations Specialist to support the execution and ongoing improvement of CTI’s Risk-Based Quality Management framework across the clinical trial portfolio.

You will coordinate Integrated Quality and Risk Management Plans (IQRMPs), assist with RACT/RMP/IDRP, maintain RBQM documentation, and collaborate with clinical operations, data management, quality, medical monitoring, and biostatistics to ensure proactive risk oversight

Qualifications

• Experience in clinical research, data management, monitoring, quality, or similar role in CRO/pharma/healthcare
• Knowledge of RBQM concepts including KRIs and centralized monitoring
• Familiarity with ICH E6(R2/R3) guidelines

Responsibilities

• Coordinate development and maintenance of Integrated Quality and Risk Management Plans (IQRMPs)
• Support RBQM activities including RACT, RMP, and IDRP
• Facilitate cross-functional risk review meetings and track actions to completion
• Maintain RBQM documentation, trackers, logs, templates, and SharePoint resources
• Coordinate RBQM trial-specific activities and ensure trial team accountability
• Support centralized monitoring activities and risk review preparation

Job description

CTI Clinical Trial Services Inc. is seeking an entry- to mid-level RBQM Operations Specialist to support the execution and ongoing improvement of CTI’s Risk-Based Quality Management framework across the clinical trial portfolio.

You will coordinate Integrated Quality and Risk Management Plans (IQRMPs), assist with RACT/RMP/IDRP, maintain RBQM documentation, and collaborate with clinical operations, data management, quality, medical monitoring, and biostatistics to ensure proactive risk oversight