Senior Manager I, 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. Job Description QMS-TMP-12-1A-4-2 Section 1: Job Details Job Title/Role Senior Manager I, Clinical Trial Risk Analyst Department Name/Functional Area Trial Delivery Support (TDS)/Trial Risk & Integrity Management (TRIM) Location Section 2: Job Description Position Summary The Senior Manager I, Clinical Trial Risk Analyst (Sr. Mgr I CTRA), is a member of the Clinical Trial Risk Management team under Trial Risk & Integrity Management (TRIM). The Clinical Trial Risk Management capability is a critical element of the Risk Based Management (RBM) framework. Each Sr. Mgr I CTRA will be assigned a certain part of the Bristol-Myers Squibb clinical trial portfolio and will work conjunctly with their peers to ensure consistency across the function in conducting risk oversight to identify potential risks and control strategies. This role is responsible for the assessment of risk and data quality analytics that monitor issues and identify emerging risks in studyspecific variables (trends / outliers / unusual patterns) through the review of aggregate clinical and operational data leveraging powerful statistical methodologies. The Sr Mgr I CTRA will be responsible for study-level risk analysis and reporting and will be key contributor to the clinical study team to support the oversight of the sites/countries/studies for compliance, patient safety, data quality and reliability. The Sr. Mgr I CTRA role has accountability to evaluate, monitor, escalate and report risks to the Clinical Trial Risk Lead (CTRL) that could potentially have a broad significant and/or systemic impact on quality, compliance, and operational deliverables for discussion with the relevant Governance Committee. The Sr. Mgr I CTRA forms a key partnership with the CTRL, R&D Quality (Risk Governance and Operations), applicable GDO & TA functions. Duties/Responsibilities • Sr. Mgr I CTRA to contribute to, and for assigned studies may lead, the 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 Manager (GTM) or 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 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 4 Limits (QTLs). Proposal to include information on critical data, data source, data flow, data review frequency, external data transfer frequency etc. • 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 for assigned studies, drafting specifications independently. • 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 applicable functional plan. • Responsible for regular risk monitoring at study level 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, and periodically lead, 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 analytical insights back to the original risk discussions to share a compelling 'risk story'. • Drives 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. • Participates in initiatives / continuous improvement opportunities within the TRIM and broader organizations, with occasional leadership of select departmental initiatives. • 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. • Supports onboarding of new team members and provides informal guidance and peer mentoring within the TRIM group. • Takes on additional responsibilities as directed by leadership. 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 3 of 4 Reporting Relationship This role will report to a people leader within the Clinical Trial Risk Management (CTRM) organization. Qualifications 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 4 years in the pharmaceutical industry with sound understanding of drug development and 3 years of experience in clinical trial operations and/or Good Clinical Practice is required. Strong working expertise in Risk-Based Monitoring principles (Quality by Design, Risk Assessment & Control) and relevant tools (e.g. RACT, risk analytics platforms, Veeva and other quality systems). Technical expert in data analysis and interpretation using data visualizations to derive meaningful insights; and an ability to effectively tell the story of the data findings. Ability to contribute to the development and implementation of data visualizations and analyses to support Risk Management / Risk Monitoring business needs. Strong understanding of GCP, compliance and regulatory expectations. Experience of audits and health authority inspections, root cause analysis and CAPA is preferred. Proven leadership skills with an ability to influence and manage key internal stakeholders, with growing capability to engage and influence at senior stakeholder <