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The Central Monitor (CMN) plays a critical role contributing to the development, embedding, growth and health of the central monitoring capability in support of Risk Based Monitoring (RBM) methodology adopted by BMS. The CMN is responsible for the remote assessment of Risk Indicators that identify issues and emerging risks in study-specific variables (trends / outliers / poor performing sites) through the review of aggregate data. Central monitors are responsible for the review of clinical and operational data. The CMN will interact with clinical teams and regionally based Site Monitors/Managers to support the oversight of the sites/studies as per the Risk Based Monitoring methodology adopted by BMS.
Key Responsibilities and Major Duties
Support and contribute to the development, embedding, growth and health of the necessary business process to support risk mitigation and global monitoring processes that align with the risks of BMS programs and protocols.
Support execution of RBM processes as a part of cross-functional teams spanning the R&D portfolio (all therapeutic areas and phases of development).
Utilize analytics/visualizations to review aggregate data for the remote assessment of Risk Indicators that identify issues and emerging risks at the study, program, country, therapeutic and functional level, to ensure risks are addressed consistently.
Identify critical data issues and document findings for tracking and timely resolution.
Contribute to the development of or provide feedback on documented processes developed for risk based monitoring methodology being adopted by BMS.
Contribute to the development of or provide feedback on training material developed to support RBM methods.
Accountable for supporting global inspection readiness and inspections in regards to RBM monitoring process and tactics
Provide user input on IT needs necessary to support all aspects of RBM.
Contribute to the development and maintenance of metrics that inform the evaluation of central monitoring performance and effectiveness.
Accountable providing input on continuous improvement opportunities/initiatives within the GDMCM and GDO organization
Acts as a change agent with stakeholders across R&D, including educating, bridging knowledge across functions and developing effective partnerships with critical stakeholders.
University degree education equivalent to a Bachelor's required in one of the following disciplines or related field: Life Sciences; Analytics; Data Science; Statistics; Business
3+ Years in drug development
3+ Years in the field of site management, site monitoring, data management or related
Demonstrated ability to effectively communicate ideas/concepts and to motivate others to accomplish challenging shared goals and objectives.
Well-versed in analytical and conceptual capabilities
Demonstrated ability to apply critical thinking and identify, distinguish relative importance and be able to work through issues remotely
Demonstrated knowledge of clinical operations, inclusive of site monitoring, management and data management
Demonstrated knowledge of Good Clinical Practices (GCP)
Demonstrated ability to absorb critical knowledge on relevant protocol/trial design requirements as well as relevant clinical/disease area knowledge
Demonstrated ability to successfully manage competing priorities to achieve the goals of the department and the larger organization.
Thorough knowledge of global regulatory and guideline (inclusive of ICH GCP) requirements with clinical experiences in a drug development capacity
Demonstrated ability to build and maintain strong relationships across organizational and/or geographic boundaries through participation on cross-functional teams.
Basic office tools (e.g. MS Suite); BMS tools (e.g. HRConnect, SuccessFactors Learning)
Thorough knowledge of software and tools used for Central Monitoring activities (e.g. SAS and J-review reports; clinSIGHT; MS Excel); any new software identified to enhance the CMN role.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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.