Manager, Risk Based Quality Management

CTI; Covington (KY); Hybrid; USD 75,000 - 110,000; Full time

Benefits offered by this job

Health benefits

Hybrid work opportunities

Tuition reimbursement

Paid parental leave

Job summary

CTI Clinical Trial and Consulting Services in the United States seeks an entry to mid-level RBQM coordinator to support the Risk-Based Quality Management framework across the clinical trial portfolio. You will coordinate IQRMPs, RACT/RMP/IDRP activities, and risk review meetings under RBQM leadership.

This role emphasizes operational execution, documentation governance, and collaboration with data management, biostatistics, and medical monitoring, using tools like CluePoints and Medidata.

Qualifications

• Bachelor’s degree in health, life sciences, or related field or equivalent experience.
• At least 2 years in clinical research, data management, monitoring, quality, or similar role.
• Basic understanding of clinical trial operations and GCP.
• Experience with RBQM concepts, KRIs and centralized monitoring.
• Familiarity with ICH E6(R2/R3) guidelines and trial systems.

Responsibilities

• Coordinate development and maintenance of Integrated Quality and Risk Management Plans (IQRMPs).
• Support and coordinate RACT, RMP, and IDRP activities, including protocol review.
• Facilitate cross-functional risk review meetings and track action items.
• Maintain RBQM documentation, trackers, logs, and SharePoint resources.
• Coordinate RBQM trial-specific activities and ensure team accountability.
• Support centralized monitoring and risk review preparation and meetings.
• Partner with PM, Data Management, Quality, Medical Monitoring, Biostatistics.
• Utilize RBQM platforms to support monitoring and documentation.
• Contribute to process improvement initiatives related to RBQM execution.

Skills

RBQM concepts

Quality monitoring

Cross-functional

Data management

Regulatory knowledge

Education

Bachelor’s degree in health, life sciences, or related field

Tools

CluePoints

Medidata

EDC systems

Job description

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
• 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

What You'll Bring:

• Bachelor’s degree in health, life sciences, or related field, or equivalent combination of education and experience
• At least 2 years of experience in clinical research, data management, monitoring, quality, or similar role in a CRO, pharmaceutical, or healthcare setting
• Basic understanding of clinical trial operations and Good Clinical Practice (GCP)
• Experience reviewing clinical data, reports, or study metrics preferred
• Experience with RBQM concepts, including KRIs, risk assessments, or centralized monitoring
• Familiarity with ICH E6(R2/R3) guidelines
• Experience working with clinical trial systems (e.g., EDC, RBQM tools such as CluePoints or Medidata)
• Prior experience supporting risk review processes, data review, or quality oversight activities

About CTI

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

Why CTI?

• Advance Your Career – We invest in your professional growth. Through a structured mentoring program, leadership development courses, and access to ongoing education and training opportunities, including tuition reimbursement, you’ll have the tools to achieve your goals. Our dedicated training department supports your successful career at CTI.
• Be Part of an Award-Winning Team – Join a global team spanning 60 countries, recognized for its award-winning culture that prioritizes people. We support your work-life balance with generous health benefits, vacation packages, hybrid work opportunities, and paid parental leave. Through our CTI Cares program, you’ll have opportunities to give back to your community and the world.
• Make a Lasting Impact – At CTI, your work directly contributes to advancing medicine. You’ll play a vital role in developing life-changing treatments for patients with chronic and critical illnesses. Together, we move medicine forward, making a difference for those who need it most

Equal Opportunity Employer/Veterans/Disabled