Bristol-Myers Squibb Company

Senior Central Monitor

Location
Princeton, NJ, United States
Posted
May 29, 2019
Ref
R1512177
Required Education
Bachelors Degree
Position Type
Full time
The Senior 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 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.

Key Responsibilities and Major Duties
  • 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 required; preferred in one of the following disciplines or related field: Life Sciences; Analytics; Data Science; Statistics; Business;
  • Experience - Responsibility and minimum number of years: 5+ Years in drug development;
  • 3+ Years in the field of site management, site monitoring, data management or related
  • Competencies - knowledge, skills, abilities, other: 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.
  • Software that must be used independently and without assistance (e.g., Microsoft Suite): 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).


Travel Required (nature and frequency): If not HQ based, potential need for periodic travel to HQ where team may be located.