Manager, Risk Based Quality Management
About The Position
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.
Requirements
- 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
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
Benefits
- Generous health benefits
- Vacation packages
- Hybrid work from home opportunities
- Paid parental leave
- Tuition reimbursement
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
