Sr. Central Monitor
About the Job
The Central Monitor 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 being adopted by BMS. The Central Monitor 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 can be located at BMS facilities worldwide and will be responsible for the review of clinical and operational data. The Central Monitor will interact with HQ clinical teams and regionally based Site Monitors/Managers to support the oversight of the sites/studies as per the Risk Based Monitoring methodology being adopted by BMS.
- Support & contribute to the development, embedding, growth & health of the necessary business process to support risk mitigation & global monitoring processes.
- Support execution of RBM processes as a part of x-functional teams spanning the R&D portfolio (all TAs & phases of dev).
- Use analytics/visualizations to review aggregate data for the remote assessment of Risk Indicators that identify issues & emerging risks at the study, program, country, TA and functional level, to ensure risks are addressed consistently.
- Identify critical data issues & document findings for tracking and timely resolution.
- Contribute to the development of and provide feedback on documented processes developed for RBM methodology being adopted by BMS.
- Contribute to the development of and provide feedback on training material is 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.
- As a member of the department, is accountable to provide input on Continuous Improvement opportunities within Global Clinical Operations
- Acts as a change agent with stakeholders across R&D, as RBM is embedded as a core capability. Including\: educating, bridging knowledge across functions and developing effective partnerships with critical stakeholders.
- Degree preferred in one of the following disciplines or related fields\: Life Sciences, Analytics, Data Science, Statistics, Informatics, Business.
- Five plus years in drug development and three plus years in the field of data management, site management, site monitoring or related.
- Primary location in Princeton.