Manager, Risk Based Quality Management

🔥 15 hours ago

🐎 Kentucky – Remote

🐎 Kentucky – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🎲 Risk

👻 Ghost score 10%

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CTI Clinical Trial and Consulting Services

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1999

💼 Consulting

🏥 Healthcare

🧬 Biotechnology

Consulting • Healthcare • Biotechnology

CTI Clinical Trial and Consulting Services is a full-service contract research organization (CRO) that provides clinical trial execution, regulatory strategy, lab and bioanalytical services, real-world evidence generation, and research center management to biotech and pharmaceutical sponsors. With expertise across Phase I–IV studies and complex therapeutic areas (including rare diseases, cell and gene therapy, oncology, neurology, and transplantation), CTI supports study design, site management, patient recruitment, monitoring, safety/pharmacovigilance, biometrics, and quality assurance. Headquartered in Covington, KY, the company emphasizes integrated, patient-centric approaches and global regulatory guidance to accelerate development and bring therapies to patients.

📋 Description

• Support execution, operationalization, sustainability, and continuous improvement of CTI’s Risk-Based Quality Management framework across the clinical trial portfolio • 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 track action items to completion • Maintain RBQM documentation, trackers, logs, templates, and SharePoint resources • Coordinate trial-specific RBQM activities and ensure trial team accountability • Support routine centralized monitoring, including KRI/QTL review activities and risk review preparation • Partner with Clinical Project Management, Data Management, Quality, Medical Monitoring, Biostatistics, and other functional teams • Assist the Director, RBQM with strategic, operational, and client-facing initiatives • Utilize BI RBQM tools, CluePoints, Medidata, and other platforms for monitoring and documentation • Contribute to process improvement initiatives related to RBQM execution, tools, and documentation

🎯 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 with RBQM concepts, including KRIs, risk assessments, or centralized monitoring • Familiarity with ICH E6(R2/R3) guidelines • Experience working with clinical trial systems, including EDC and RBQM tools such as CluePoints or Medidata • Prior experience supporting risk review processes, data review, or quality oversight activities • Experience reviewing clinical data, reports, or study metrics preferred

🏖️ Benefits

• Structured mentoring program • Leadership courses • Tuition reimbursement • Dedicated training department • Generous health benefits • Vacation packages • Hybrid work from home opportunities • Paid parental leave • CTI Cares program • Work-life balance support