Manager, Risk Based Quality Management

CTI Clinical Trial and Consulting Services; Covington (KY); On-site; USD 70,000 - 110,000; Full time

Benefits offered by this job

Hybrid work from home opportunities

Health benefits

Vacation packages

Tuition reimbursement

Job summary

CTI Clinical Trial and Consulting Services is seeking an entry- to mid-level RBQM operations professional to support the Risk-Based Quality Management framework across our clinical trial portfolio. You will coordinate IQRMP activities, manage RACT/RMP/IDRP tasks, and help maintain RBQM documentation under leadership guidance.

Work with Clinical Project Management and functional partners to drive proactive risk oversight, issue resolution, and documentation governance, ensuring consistent RBQM

Qualifications

• Minimum 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 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).

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.
• 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.

Skills

RBQM concepts

KRIs & risk assessment

Cross-functional collaboration

Clinical trial data experience

Education

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

Tools

CluePoints

Medidata

EDC

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 support career progression through a structured mentoring program and leadership courses that provide the support needed to grow. We also value ongoing education and training through tuition reimbursement and a dedicated training department.
• Join an Award-Winning and Valued Team – We have an award-winning unparalleled culture that can be felt by our employees across 60 countries. We support a work-life balance and the importance of time with family by offering generous health benefits and vacation packages, hybrid work from home opportunities, and paid parental leave. We also encourage care for the world around us through our unique CTI Cares program.
• Make a Lasting Impact – We focus on moving medicine forward by working on treatments for chronically and critically‑ill patients, who depend on us to bring life‑changing therapies to market.

Equal Opportunity Employer/Veterans/Disabled