Sr. Central Monitor
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. 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 the resources to pursue their goals, both at work and in their personal lives.
The Sr. Central Monitor (Sr. CMN) plays a critical role contributing to the embedding, growth and health of the centralized monitoring capability in support of Risk Based Monitoring (RBM) methodology adopted by BMS. The Sr. 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. Sr. CMN can be located at BMS facilities worldwide and is responsible for the review of clinical and operational data. The Sr. CMN will interact with HQ clinical teams and regionally based Site Monitors/Managers to support the quality oversight of sites, countries and studies.
- Support & contribute to the embedding, growth & health of the necessary business processes to support risk management & global monitoring processes.
- Support execution of RBM processes as a part of cross-functional teams spanning the R&D portfolio (all TAs & phases of dev).
- Use of 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, and to ensure risks are addressed consistently.
- Identify critical data issues & document findings for tracking and timely resolution.
- Contribute to the development of, and ongoing enhancements to RBM processes and training materials.
- Accountable for supporting global inspection readiness in regards to RBM monitoring processes 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 CMN 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 (as RBM is embedded as core capability) with stakeholders across R&D, which includes 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, Finance.
- 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.