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Senior Manager, Centralized Monitoring - Princeton, NJ, United States - Bristol-Myers Squibb
Description
Working with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department.From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it.
You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity.
Take your career farther than you thought possible.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 with the resources to pursue their goals, both at work and in their personal lives.
Read more:
Development Operations (GDO) is accountable for the execution and management of R&D development studies. Clinical Compliance & Risk Management (CCRM) is accountable for driving risk planning, identification and management for studies spanning the R&D portfolio.
Position Summary The Senior Manager, Centralized Monitoring has a critical role in the development, embedding, growth and health of the central monitoring capability in support of the BMS Risk Based Monitoring (RBM) methodology.
This role is responsible for the remote assessment of Risk Indicators and analytics that allows for early issue detection and emerging risks in study-specific variables (patterns / trends / outliers / poor performing sites) through the review of aggregate clinical and operational data.
The Senior Manager, Centralized Monitoring will interact with clinical teams to support the oversight of the sites/countries/studies as per the BMS Risk Based Monitoring methodology.
Position ResponsibilitiesSupport 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).Provides input to protocol design, critical data and process identification, study risk assessment, and preventative mitigation plans.
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.
Assess the reliability of data generated through the identification of missing and/or inconsistent data, outliers, unexpected lack of or excessive variability, systematic or significant errors in data collection, and potential data manipulation or data integrity problems within and across sites.
Identify critical data issues and document findings for tracking and timely resolution.Drive the development of and provide feedback on documented processes developed for the BMS RBM methodology.
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 tacticsProvide user input to technology needs necessary to support all aspects of RBM.
Where appropriate lead development and implementation of analytical tools to support Centralized Monitoring business needs.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 CCRM and GDO organizations.
Acts as a change agent with stakeholders across Drug Development, including educating, bridging knowledge across functions, and developing effective partnerships with critical stakeholders.
Provides effective vendor oversight of outsourced studies, as assigned.Supports and contributes to successful achievement of organizational, departmental and team objectives.
RequirementsDegree required in one of the following disciplines or related field:
Life Sciences; Analytics; Data Science; Statistics; Business5+ Years in drug development3+ Years in the field of site management, site monitoring, data management or other relevant experienceKey Competency RequirementsDemonstrated ability to effectively communicate ideas/concepts and to motivate others to accomplish challenging shared goals and objectives.
Well-versed in analytical and conceptual capabilitiesDemonstrated 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 managementDemonstrated 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.
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 capacityDemonstrated 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); Thorough knowledge of software and tools used for Central Monitoring activities; any new software identified to enhance the role of the Senior Manager.Ability to lead development and implementation of data visualizations and statistical models (e.g., using R, RStudio, Python, Spotfire) to support business needs.
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway.
You could be one step away from work that will transform your life and career.Uniquely Interesting Work, Life-changing CareersWith a single vision as inspiring as "Transforming patients' lives through science ", every BMS employee plays an integral role in work that goes far beyond ordinary.
Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site ProtocolPhysical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles.
Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer.If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to Visit to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities.As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
