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Working with Us Challenging. 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. Take your career farther than you thought possible. Position Summary The Head of RCO Monitoring Excellence and Support, reporting to the Head of Regional Clinical Operations (RCO), provides strategic and tactical direction and oversight for clinical study and site monitoring processes within the Quality Management System and Business Process Management Architecture. The Monitoring Excellence Head drives end-to-end functional excellence in clinical trial monitoring, fosters collaboration within the organization across global and country teams with the business across all BMS programs and trials. This role ensures that monitoring activities are aligned with organizational priorities, regulatory requirements delivering optimized trial oversight, and risk-based monitoring performance. This role will serve as a Global Process Owner (GPO), leading decision-making and oversight to Global Process Leads (GPL) and Clinical Business Systems Leads (CBSL) to drive process optimization, oversight, and continuous improvement. This role leads a global multifunctional team to ensure excellence and innovation in monitoring strategy and execution. Additionally, this role will set the vision and build a centralized training capability to drive excellence in clinical trial monitoring, Key Responsibilities Develop and maintain global process, procedural documents, and training materials in compliance with GCP requirements and internal quality standards. Develop, implement, and manage monitoring strategies, including risk-based monitoring, study conduct, study oversight approaches, and methodology. Establish a center of excellence for monitoring, developing and disseminating best practices across the organization. Implement and oversee process monitoring methods, including data collection and analysis, metrics and associated targets, and reporting mechanisms including both product, clinical trial quality, system utilization and process effectiveness. Drive continuous improvement efforts through data-driven decision-making and collaboration with cross-functional stakeholders. Maintain global expertise through external partnerships, ongoing training, and participation in industry forums. Develop, deploy, and manage a Monitoring Strategy and Execution team which serves as the SMEs for all risk-based monitoring, study conduct and study oversight approaches. Develop and implement a monitoring oversight strategy, inclusive of managing both internally and external vendor(s) to ensure quality and compliance with applicable policies and procedures as outlined in study-specific monitoring plans. Develop and implement strategies for business continuity in monitoring and clinical study / site management. Maintain inspection readiness storyboards for Clinical Study and Site Management processes and support Health Authority Inspections. Supervise and coordinate the work assignments and performance of Monitoring Excellence and Support staff to ensure timely execution consistent with R&D research goals and priorities. Qualifications & Experience A minimum of 10 years pharmaceutical industry experience in Clinical Research or Medical Affairs. Significant monitoring experience required. Experience in the planning, conduct and management of clinical programs (Phase I-IV). Demonstrated ability to drive project related activities. Previous experience leading, managing, coaching, and developing direct reports. In depth understanding of GCP, ICH Guidelines and other local guidance, regulation and codes of practice related to Clinical Research and Medical Affairs. In depth knowledge and understanding of clinical research processes, regulations, and methodology. Ability to manage and lead complex regional and / or global initiatives. Understands clinical landscape with practical knowledge of a variety of medical settings and medical records management. Demonstrated organizational and planning skills and independent decision-making ability. Strong organization and time management skills and ability to effectively manage multiple competing priorities. Outstanding interpersonal, oral, and written communication skills to influence, inform or guide others. Compensation Overview Field - United States - US : $233,780 - $283,291 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportun #J-18808-Ljbffr
