Lead Manager, Centralized Oversight

2 weeks ago


Princeton, New Jersey, United States Bristol-Myers Squibb Company Full time
Join Us at Bristol Myers Squibb
At Bristol Myers Squibb, we redefine the meaning of work. Here, every day presents unique challenges and opportunities that are both impactful and fulfilling.

From enhancing production efficiency to pioneering advancements in cell therapy, our work has the power to change lives—both for patients and for those who contribute to this mission.

We offer an environment where you can flourish and advance your career through exceptional opportunities, all while being part of diverse, high-performing teams.

Position Overview
The Lead Manager, Centralized Oversight plays a pivotal role in the evolution and sustainability of our central monitoring capabilities, aligned with the BMS Risk-Based Monitoring (RBM) framework.

This position is tasked with the remote evaluation of Risk Indicators and analytics, facilitating early detection of issues and potential risks related to study-specific variables, including patterns, trends, outliers, and underperforming sites through comprehensive analysis of clinical and operational data.

Key Responsibilities
- Champion the development and integration of business processes that support risk mitigation and global monitoring strategies in line with BMS program and protocol risks.
- Collaborate with cross-functional teams to implement RBM processes across the R&D portfolio, encompassing all therapeutic areas and developmental phases.
- Provide insights for protocol design, identify critical data and processes, assess study risks, and develop preventative strategies.
- Utilize advanced analytics and visualizations to assess aggregate data for the remote evaluation of Risk Indicators, ensuring consistent risk management at various levels.
- Scrutinize data reliability by identifying inconsistencies, outliers, and potential data integrity issues across sites.
- Document critical data findings for effective tracking and resolution.
- Contribute to the creation and refinement of documented processes and training materials supporting RBM methodologies.
- Ensure global inspection readiness and manage inspections related to RBM monitoring processes.
- Lead the development and implementation of analytical tools to fulfill Centralized Monitoring requirements.
- Establish and maintain metrics that evaluate the performance and effectiveness of central monitoring efforts.
- Drive continuous improvement initiatives within the Clinical Compliance & Risk Management and Global Development Operations teams.

Qualifications
- A degree in Life Sciences, Analytics, Data Science, Statistics, Business, or a related field.
- A minimum of 5 years in drug development, with at least 3 years in site management, monitoring, or data management.
- Proven ability to communicate effectively and inspire teams to achieve shared objectives.
- Strong analytical and conceptual skills, with a knack for critical thinking and problem-solving remotely.
- Comprehensive knowledge of clinical operations, including site monitoring and data management, as well as Good Clinical Practices (GCP).
- Familiarity with global regulatory requirements and clinical trial design.

At Bristol Myers Squibb, we believe in empowering our employees to leverage their unique talents and perspectives in an inclusive culture that values diversity.
Join us in our mission to transform patients' lives through science.



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