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.
Global Data Management and Centralized Monitoring, which is part of Global Clinical Operations. Global Clinical Operations is accountable for the execution and management of R&D development studies. Global Data Management and Centralized Monitoring is accountable for the data capture, integration, review, quality and governance for studies spanning the R&D portfolio.
Purpose/Objective of the job
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 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 in Central New Jersey and Braine l'Alleude, Belgiumand 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 and drive 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 and drive 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.
Drive the development of and provide feedback on documented processes developed for risk based monitoring methodology being adopted by BMS.
Drive the development of and 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 Risk Based Monitoring.
Drive the development and maintenance of metrics that inform the evaluation of central monitoring performance and effectiveness.
Accountable to lead and provide input on continuous improvement opportunities/initiatives within the GDM.CM and GCO organization
Acts as a change agent with stakeholders across R&D, as RBM is embedded as a core capability. Inclusive of educating, bridging knowledge across functions and developing effective partnerships with critical stakeholders.
Has significant interfaces within BMS and externally
Degree/Certification/Licensure: University degree education equivalent to a Bachelor's is required; Science / mathematics / statistics concentrations preferred, as is MS level education
Experience: 5+ 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
Well-versed in BMS processes and procedures (including documentation requirements and issue management requirements)
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; SMT; MS Excel); any new software identified to enhance the CMN role (e.g. SpotFire, CSA).
If not HQ based, potential need for periodic travel to HQ where team may be located.
Overnight Absences Required
Depending on travel schedule and distance of HQ from home location