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 in Central New Jersey, USA and Braine l'Alleude, Belgium, 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.
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 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 Risk Based Monitoring.
Contribute to the development and maintenance of metrics that inform the evaluation of central monitoring performance and effectiveness.
Accountable for providing input on continuous improvement opportunities within GDM.CM
Acts as a change agent with stakeholders 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 (please see below):
Internal: Central Monitors; GDM.CM SLT; GCO ELT; Site Monitors; Site Managers; Protocol Data Managers; Protocol Managers; Ops Leads; DM Lead; HUMs; Clinical Scientist; Medical Monitors; Study Directors; FDT/Data Chain members involved in data quality and monitoring activities (e.g. Medical Monitors; Biostatisticians; etc...)
External: Site staff; TransCelerate RBM Initiative participants; Vendors/CROs supporting RBM review activities as well as those providing trial execution support to BMS sponsored studies.
University degree education equivalent to a Bachelor's required. Science / mathematics / statistics concentrations preferred, as is MS level education.
3+ Years in drug development
3+ Years in the field of site management and/orsite monitoring (preferred), 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) - preferred
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) - required
BMS tools (e.g. HRConnect, SuccessFactors Learning, clinSIGHT) - preferred
Thorough knowledge of software and tools used for Central Monitoring activities (e.g. SAS, SpotFireand J-review reports) - preferred
Travel Required /Overnight Absences
If not HQ based, potential need for periodic travel to HQ where team may be located.