Manager, Clinical Trial Risk Analyst

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it. Duties/Responsibilities Mgr CTRA to contribute to Protocol De-risking process, support identification of critical to success factors, critical to quality factors - including critical data, critical processes  Collaborate with the Data Management Lead (DML), Statistician, Global Trial Lead (GTL), Quality Lead, Clinical Trial Physician, Clinical Scientist and other study team members to put together an initial proposal on KRIs (standard and study specific) and Quality Tolerance Limits (QTLs). Proposal to include information on critical data, data source, data flow, data review frequency, external data transfer frequency etc. Individuals printing or viewing a BMS controlled document from a source other than the Electronic Document Management System are responsible for ensuring that they are printing or viewing the current version. Page 2 of 3  Responsible to lead and collaborate with the study team in the development of specifications to set up the KRIs, Data Quality Assessments (DQA) and QTLs.  Partners with the DML and other data review functions to determine the holistic data review strategy for the study and determines the function specific review objectives/analytics. Documents the Risk Monitoring data analysis responsibilities in the relevant functional plan.  Responsible for regular risk monitoring at study level for and providing a holistic risk report at the agreed frequency. Ensure appropriate escalations of emerging risks (including QTL deviations) to the CTRL to be discussed at relevant governance bodies (e.g. Quality Council/Therapeutic Area leadership) and proactively shares knowledge and insights across the TRIM group.  Triages new and previously open signals in preparation for the Risk Review Meetings (RRM) to prioritize the signals for discussion and prepare a list of recommended actions  Contribute to the Risk Review discussion to determine if newly opened signals reveal potential risks and require follow-up investigation and if previously opened signals can be closed or need further investigation/monitoring/action. Relates the insights from the CM analysis back to the original risk discussions to share a compelling ‘risk story’.  Drives or contributes to ongoing risk discussions within the study team throughout the lifecycle of the trial and ensures the risk management plan is updated and remains current  Contribute to the development and maintenance of metrics that inform the evaluation of risk monitoring performance and effectiveness.  Participation in initiatives / continuous improvement opportunities within the TRIM and broader organizations  Supports the strategic direction of Risk Based Management within the business to include leadership of RBM innovation, education and embedding  Ensure effective quality oversight and management of external partners (e.g. Function Service Providers, CROs, technology providers, etc.) performing Risk Management or Risk Monitoring activities on behalf of BMS  Takes on additional responsibilities as directed by leadership Reporting Relationship This role will report to a Clinical Trial Risk Analyst Line Manager within the TRIM organization.

A minimum of a bachelor’s degree in one of the following disciplines or related field: Life Sciences (preferred); Analytics; Data Science; Statistics; Business; is required. At least 3 years in the pharmaceutical industry with sound