Sr. Manager. Clinical Trial Risk Analyst

Working with Us Challenging. 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 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...