Job
Description
The Sr. Mgr 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 role has accountability to evaluate, monitor, escalate and report risks to the AD Risk Management and Central Monitoring 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 forms a key partnership with the AD Risk Management and Central Monitoring, R&D Quality (Risk Governance and Operations), applicable GDO & TA functions. Duties/Responsibilities Sr. Mgr 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. 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 Central Monitoring data analysis responsibilities in the Integrated Data Review 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 AD Risk Management and Central Monitoring 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 Integrated Risk Management Plan (IRMP) 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 CORM 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 Central 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 an Associate Director, Risk Management and Central Monitoring within the CORM 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 years in the pharmaceutical industry with a sound understanding of drug development and 3 years of experience in clinical trial operations and/or Good Clinical Practice is required. Demonstrated 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 / Central Monitoring business needs. In depth understanding of GCP, compliance and regulatory expectations. Experience of audits and health authority inspections, root cause analysis and CAPA is preferred. Advanced Leadership skills with an ability to influence and manage key internal stakeholders including at the Senior Leadership Level Excellent communication, collaboration and teamwork skills with an ability to drive cross-functional stakeholders to consensus. An ability to create a compelling story based on data insights which is meaningful to the target audience.
