Note: The job is a remote job and is open to candidates in USA. KPS Life is seeking a Senior Manager, RBQM Data Analyst to support global clinical trials through advanced data analysis and risk-based quality management. The role leads analytical reviews, identifies and communicates study risks, and serves as a subject matter expert for RBQM systems, including CluePoints.

Responsibilities

• Develop and maintain Central Monitoring Plans and contribute to study-level quality risk assessments and risk mitigation strategies
• Lead analytical reviews across assigned studies, interpreting Key Risk Indicators (KRIs), Key Performance Indicators (KPIs), Quality Tolerance Limits (QTLs), and supporting clinical and operational data
• Evaluate relationships across data sources to identify anomalies, emerging trends, and potential risks to patient safety, data integrity, and study quality
• Present findings to cross-functional study teams, explain their significance and potential root causes, and recommend appropriate investigation or follow-up
• Document analytical findings, study team decisions, and agreed actions; track issues through resolution
• Serve as a subject matter expert for CluePoints and other RBQM systems, supporting study configuration, implementation, troubleshooting, and consistent use
• Maintain standardized KRI and QTL libraries and collaborate with stakeholders to develop system configuration specifications and data transfer agreements
• Support RBQM vendor oversight, including system performance, timelines, updates, and issue resolution
• Develop and enhance analytical tools, reports, dashboards, processes, and training materials to strengthen data review capabilities
• Mentor junior colleagues, provide technical guidance, and contribute to cross-functional process improvement initiatives

Skills

• Bachelor's degree with 8–10 years of relevant biotechnology, pharmaceutical, or clinical research industry experience, or an advanced degree with 6–8 years of relevant experience
• Substantial experience in RBQM-related activities, with a strong emphasis on data analysis and interpretation
• At least 3 years of direct, hands-on RBQM systems experience, including at least 2 years working directly in CluePoints
• Demonstrated ability to independently analyze complex clinical trial data, investigate risk signals, and communicate actionable findings
• Strong analytical problem-solving, critical thinking, and understanding of statistical and mathematical concepts
• Technical experience with databases, systems, report development, and programming languages, including a statistical programming language
• Knowledge of clinical databases, electronic data capture systems, data quality controls, and auditing procedures
• Working knowledge of clinical drug development, ICH guidelines, Good Clinical Practice (GCP), and applicable regulations
• Ability to explain complex analytical findings clearly to technical and nontechnical stakeholders
• Strong collaboration, communication, and organizational skills, with the ability to manage priorities across multiple studies
• Proficiency in Microsoft Office applications, including Excel and PowerPoint
• Experience supporting global or complex clinical trials; central monitoring, clinical data management, or site monitoring experience is beneficial

Benefits

• Remote work in the United States

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