Sr. Manager, Clinical Trial Risk Analyst

Working with UsChallenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.Position Summary:The Senior Manager, Clinical Trial Risk Analyst (Sr. Mgr CTRA), is a memberof the Clinical Trial Risk Management team under Trial Risk & IntegrityManagement (TRIM). The Clinical Trial Risk Management capability is a critical element of the RiskBased Management (RBM) framework. Each Sr. Mgr CTRA will be assigned a certain part of the Bristol-Myers Squibbclinical trial portfolio and will work conjunctly with their peers to ensure consistency across the function in conducting risk oversight to identify potentialrisks and control strategies. This role is responsible for the remote assessment of risk and data quality analytics that monitor issues and identify emerging risks instudy-specific variables (trends / outliers / unusual patterns) through the review of aggregate clinical and operational data leveraging powerful statisticalmethodologies. The Sr. Mgr 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 ofthe sites/countries/studies for compliance, patient safety, data quality and reliability. The Sr. Mgr CTRA role has accountability to evaluate, monitor, escalate andreport risks to the Clinical Trial Risk Lead (CTRL) that could potentially have a broad significant and/or systemic impact on quality, compliance, and operationaldeliverables for discussion with the relevant Governance Committee. The Sr. Mgr CTRA forms a key partnership with the CTRL, R&D Quality (RiskGovernance and Operations), applicable GDO & TA functions.Duties/Responsibilities:Sr. Mgr CTRA to lead or contribute to Protocol De-risking process, supportidentification of critical to success factors, critical to quality factors -including critical data, critical processes Collaborate with the Data Management Lead (DML), Statistician, GlobalTrial Manager (GTM), Quality Lead, Clinical Trial Physician, ClinicalScientist and other study team members to put together an initial proposal onKRIs (standard and study specific) and Quality Tolerance Limits (QTLs).Proposal to include information on critical data, data source, data flow, datareview frequency, external data transfer frequency etc.Individuals printing or viewing a BMS controlled document from a source other than the Electronic Document Management System areresponsible for ensuring that they are printing or viewing the current version. Responsible to lead and collaborate with the study team in the developmentof specifications to set up the KRIs, Data Quality Assessments (DQA) andQTLs. Partners with the DML and other data review functions to determine theholistic data review strategy for the study and determines the function specificreview objectives/analytics. Documents the Risk Monitoring dataanalysis responsibilities in the applicable functional plan. Responsible for regular risk monitoring at study level for priority studies andproviding a holistic risk report at the agreed frequency. Ensure appropriateescalations of emerging risks (including QTL deviations) to the CTRL to bediscussed at relevant governance bodies (e.g Quality Council/TherapeuticArea leadership) and proactively shares knowledge and insights across theCORM group. Triages new and previously open signals in preparation for the Risk ReviewMeetings (RRM) to prioritize the signals for discussion and prepare a list ofrecommended actions Lead or contribute to the Risk Review discussion to determine if newlyopened signals reveal potential risks and require follow-up investigation andif previously opened signals can be closed or need furtherinvestigation/monitoring/action. Relates the insights from the CM analysisback to the original risk discussions to share a compelling ‘risk story’. Drives ongoing risk discussions within the study team throughout thelifecycle of the trial and ensures the risk management plan is updated andremains current Contribute to the development and maintenance of metrics that inform theevaluation of risk monitoring performance and effectiveness. Leadership or participation in initiatives / continuous improvementopportunities within the TRIM and broader organizations Supports the strategic direction of Risk Based Management within thebusiness 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.) performingRisk Management or Risk Monitoring activities on behalf of BMS Coach, mentor and develop new team members. Takes on additional responsibilities as directed by leadershipReporting Relationship: This role will report to a Clinical Trial Risk Analyst Line Manager within the TRIM organization.Qualifications: A minimum of a bachelor’s degree in one of the following disciplines or relatedfield: Life Sciences (preferred); Analytics; Data Science; Statistics; Business; isrequired.At least 5 years in the pharmaceutical industry with sound understanding of drugdevelopment and 3 years of experience in clinical trial operations and/or Go