Senior Manager, Clinical Trial Risk Analyst

Responsibilities

• Perform remote assessment of risk and data quality analytics to monitor issues and identify emerging risks in clinical trial portfolios.
• Lead or contribute to the Protocol De-risking process, supporting the identification of critical-to-quality factors including data and processes.
• Collaborate with study teams (Data Management, Statistics, Clinical Scientists) to develop Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs).
• Conduct regular study-level risk monitoring and provide holistic risk reports to ensure compliance, patient safety, and data reliability.
• Triage signals and lead Risk Review discussions to determine if new findings require follow-up investigation or action.
• Drive ongoing risk discussions throughout the trial lifecycle and ensure risk management plans remain current.
• Ensure effective quality oversight of external partners, including CROs and technology providers.
• Coach and mentor new team members within the Clinical Trial Risk Management team.

Requirements

• Bachelor's degree in Life Sciences, Analytics, Data Science, Statistics, or Business.
• 5+ years of experience in the pharmaceutical industry with a sound understanding of drug development.
• 3+ years of experience in clinical trial operations and/or Good Clinical Practice (GCP).
• Demonstrated expertise in Risk-Based Monitoring (RBM) principles, including Quality by Design and Risk Assessment & Control.
• Proficiency in data analysis and interpretation using data visualizations to derive and communicate meaningful insights.
• In-depth understanding of GCP, regulatory expectations, and compliance standards.

Preferred Qualifications

• Experience with risk analytics platforms, Veeva, or other quality management systems.
• Experience with audits, health authority inspections, root cause analysis, and CAPA processes.
• Advanced leadership skills with the ability to influence key internal stakeholders and senior leadership.

About the Company

Bristol Myers Squibb is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients prevail against serious diseases. We foster a culture of inclusion, integrity, and high achievement to transform lives through science.