Location: United States, United States | Type: Remote | Country: USJob 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 assessmentFacilitate cross-functional risk review meetings and ensure action items are tracked to completionMaintain RBQM documentation, trackers, logs, templates, and SharePoint resourcesCoordinate RBQM trial specific, activities, and ensure trial team accountabilitySupport routine centralized monitoring (KRI/QTL review) activities and risk review preparation and meetingsPartner with Clinical Project Management, Data Management, Quality, Medical Monitoring, Biostatistics, and other functional teams to support RBQM executionAssist 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 activitiesContribute to process improvement initiatives related to RBQM execution, tools, and documentationWhat You'll Bring:Bachelor’s degree in health, life sciences, or related field, or equivalent combination of education and experienceAt least 2 years of experience in clinical research, data management, monitoring, quality, or similar role in a CRO, pharmaceutical, or healthcare settingBasic understanding of clinical trial operations and Good Clinical Practice (GCP)Experience reviewing clinical data, reports, or study metrics preferredExperience with RBQM concepts, including KRIs, risk assessments, or centralized monitoringFamiliarity with ICH E6(R2/R3) guidelinesExperience 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 activitiesAbout CTICTI 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 (http://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.Important Note In light of recent increase in hiring scams, if you're selected to move onto the next phase of our hiring process, a member of our team will reach out to you directly from an @ctifacts.com email address to guide you through our interview process. Please ensure you are applying for jobs directly on our website (www.ctifacts.com (http://www.ctifacts.com)) or from our verified LinkedIn page. Please NoteWe will never communicate with you directly via Microsoft Teams Messaging or by text messageWe will never ask for your bank account information at any point during the recruitment processEqual Opportunity Employer/Veterans/DisabledEqual Opportunity Employer/Protected Veterans/Individuals with Disabilities This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights (https://www.eeoc.gov/poster) notice from the Department of Labor.
19 days ago