Location: Remote, United States
Travel: Up to 25%, as needed
Position Summary
We are seeking a Senior Manager, RBQM Data Analyst to support global clinical trials through advanced data analysis and risk-based quality management (RBQM). This role focuses on interpreting clinical and operational data, identifying meaningful trends and potential risks, and translating findings into actionable recommendations for clinical study teams.
The successful candidate will bring strong analytical expertise, hands-on CluePoints experience, and the ability to independently lead data reviews across multiple studies. This position also serves as a subject matter expert for RBQM systems, supporting configuration, implementation, governance, and continuous improvement.
Key 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.
- 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.
- Experience supporting global or complex clinical trials; central monitoring, clinical data management, or site monitoring experience is beneficial.
- 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.