Head of RCO Monitoring Excellence and Support
Bristol Myers Squibb
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.
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: careers.bms.com/working-with-us.
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. 
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.
Compensation Overview:
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. 
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit  https://careers.bms.com/life-at-bms/.
Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.
Uniquely Interesting Work, Life-changing Careers
With 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 a supportive culture, promoting global participation 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 Protocol
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
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 adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility 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.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
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