A Clinical Quality Manager ensures that the quality of the work in a clinical environment is consistent and meets government and industry standards as well as customer expectations. Verifies compliance with health and safety regulations. Coordinates all activities related to quality assurance and monitoring and revises existing processes in order to increase efficiency.
Manager, Clinical Quality Oversight at CTI Clinical Trial Services, Inc. Manager, Clinical Quality Oversight at CTI Clinical Trial Services, Inc. in Covington, Kentucky Posted in about 19 hours ago.
Type:
Full-Time Job Description:
ESSENTIAL FUNCTIONS
Maintain advanced knowledge of ICH GCP compliance and regulatory expectations across multiple regions Provide regulatory compliance guidance and quality improvement consult to internal and external customers, ensuring global alignment Conduct protocol risk reviews and develop trial level QA Oversight Plans aligned with RBQM principles, trial phase, and identified critical‑to‑quality (CtQ) cross‑functional risks Monitor trial-level QTLs, KPIs, and communicate results to the trial team Conduct TMF and CTQ risk‑based SOP compliance assessments and targeted deep‑dive evaluations based on identified quality signals and trends Communicate compliance assessment outcomes clearly and effectively, verbally and in writing, escalating significant compliance risks to project team leadership, QA leadership, CTI executive management, and sponsor representatives as appropriate Design and deliver advanced training to trial teams on QA topics tailored to address compliance challenges identified during snapshot and deep dive compliance assessments, audits, and inspections Independent trend analysis of quality events and protocol deviations, separate from the trial team review, to detect emerging or unrecognized trends Review Major/Critical CAPAs and provide strategic guidance for action implementation, and monitor effectiveness checks Attend Project Management-led team meetings Lead or attend Client QA to QA governance touchpoint meetings Participate in regulatory inspections and mock inspections to support inspection readiness Work with CTI internal auditing function to target trial-specific CTQ processes for the internal audit schedule, as applicable Review RBQM risks when applicable for completeness and inspection readiness Maintain continuous inspection readiness through alignment of global pre‑inspection requests with controlled quality documentation Develop and implement periodic sponsor questionnaires to measure overall approval, satisfaction, and perceptions of program effectiveness Host sponsor qualification and requalification audits Mentor and lead junior-level employees as assigned
REQUIRED EDUCATION AND EXPERIENCE
Bachelor's degree or equivalent relevant experience 5 years of experience in life sciences, CRO, or similar industry Advanced knowledge of GCP guidelines, clinical trial operations, and core clinical research processes. Proficiency in the English language Certification in auditing (RQAP, ASQ) or other quality-related certification is preferred 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 ) or from our verified page. Please Note We will never communicate directly with you via Microsoft Teams Messaging or by text message We will never ask for your bank account information at any point during the recruitment process Equal 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 notice from the Department of Labor.
