Associate Director, Risk Management and Centralized Monitoring

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Position Summary

• The Associate Director, Risk Management and Central Monitoring (AD), is a member of the Risk Management and Central Monitoring team under Clinical Oversight and Risk Management (CORM).

• The Risk Management and Central Monitoring capability is a critical element of the Risk Based Management (RBM) framework and will drive and support the strategic direction of Risk Based Management within the business.

• Each AD will be assigned a significant 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 Asset/Portfolio/TU variables (trends / outliers / unusual patterns) through the review of aggregate clinical and operational data leveraging powerful statistical methodologies.

• The AD will be responsible for Asset/Portfolio/TA risk analysis and reporting and will be key contributor to the Clinical Development Team to support the oversight of compliance, patient safety, data quality and reliability.

• The AD role has accountability to evaluate, monitor, escalate and report risks to the Sr Director Risk Management and Central Monitoring and/or Global Program Team 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 AD forms a key partnership with the CORM colleagues, R&D Quality (Risk Governance and Operations), applicable GDO & TA functions and their leaders.

Duties/Responsibilities

• AD is accountable for ensuring a high quality and consistent Protocol De-risking process is applied to studies within their portion of the portfolio, resulting in a robust Integrated Risk Management Plan (IRMP) which is maintained and kept relevant throughout the lifecycle of the study

• AD ensures a high quality and consistent holistic data review strategy is applied to studies within their portion of the portfolio, resulting in a robust Integrated Data Review Plan (IDRP)

• Responsible for regular risk monitoring for their allocated portion of the portfolio and providing a holistic risk report at the agreed frequency.

• Ensure appropriate escalations of emerging risks (including QTL deviations) to the relevant governance committee (e.g. Quality Council/Therapeutic Area leadership) and proactively shares knowledge and insights across the CORM group.

• Connects the outcomes of Risk Review Meetings of studies within their portion of the portfolio to their additional risk analyses in order to feed into higher level risk logs via a compelling ‘risk story’ at asset/portfolio/TA level

• Lead or contribute to the development and maintenance of metrics that inform the evaluation of risk monitoring performance and effectiveness.

• Leadership or participation in large strategic initiatives / continuous improvement opportunities within the CORM and broader organizations

• Drive and support the strategic direction of Risk Based Management within the business to include leadership of RBM innovation (including representing the Company in interactions with key external partners as part of any committee or industry group relating to RBM), education and embedding

• Ensure effective quality oversight and management of external partners (e.g. Function Service Providers, CROs, technology provi