Sr. Manager, Clinical Trial Risk Analyst

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Position Summary: The Senior Manager, Clinical Trial Risk Analyst (Sr. Mgr 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 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 remote assessment of risk and data quality analytics that monitor issues and identify emerging risks in study-specific variables (trends / outliers / unusual patterns) through the review of aggregate clinical and operational data leveraging powerful statistical methodologies. 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 of the sites/countries/studies for compliance, patient safety, data quality and reliability. The Sr. Mgr 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 CTRA forms a key partnership with the CTRL, R&D Quality (Risk Governance and Operations), applicable GDO & TA functions. Duties/Responsibilities: Sr. Mgr CTRA to lead or 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 Manager (GTM), 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.  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 applicable functional plan.  Responsible for regular risk monitoring at study level for priority studies 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 CORM 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  Lead or 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 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.  Leadership or 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  Coach, mentor and develop new team members.  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. 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 5 yea