Sr. Manager - Clinical Site Operations
Sr. Manager - Clinical Site Operations
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Job Description
Working with Us
Challenging. Meaningful. Life-changing. Those arent 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. Youll 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: Title: Manager Clinical Site Operations
Department: Clinical
Location: Remote
Summary
The Manager Clinical Site Operations is responsible for the oversight and management of study execution activities at our clinical investigative sites. This includes oversight and management of Clinical Research Organization (CRO) Clinical Research Associates (CRAs) / monitors and Investigator Sites. The Manager Clinical Site Operations will ensure ongoing inspection readiness data integrity and overall data quality according to and in compliance with corporate and project/program Standard Operating Procedures (SOPs) Good Clinical Practice (GCP)/International Conference on Harmonization (ICH) guidelines and other applicable federal (FDA) and state regulations.
Job Responsibilities
Essential duties and responsibilities include the following. Other duties may be assigned.
Responsible for the oversight and management of assigned clinical sites and studies. This includes ensuring site execution of studies in accordance with RayzeBio SOPs ICH Guidelines and Good Clinical Practices (GCP) to ensure overall data quality integrity and patient protection
Oversight of all CRO work to ensure:
o Appropriate training of the clinical team and investigators
o Timely start-up
o Site payments are completed in a timely manner
Perform review and quality control of trial master file ensuring overall inspection readiness
Perform review of safety data to ensure all outstanding items are addresses within a timely manner
Utilize CRO systems to review Monitoring Visit Reports monitoring visit scheduling monitoring metrics protocol deviations issues and action items to ensure data quality. If items are identified that would require re-training the Manager will facilitate
Proactively identify prevent and mitigate site-specific study-related risks
Summarizes clinical site performance data and escalates risk to the Sr. Director CSO and SVP Clinical Operations as needed
Contributes to the development review and approval of site and study documents including but not limited to RayzeBio SOPs and Clinical Operation Plans
Conduct site visits to foster site relationships with RayzeBio address poor performance increase site interaction and enrollment and further ensure adequate oversight of study execution
Serve as the direct sponsor contact for sites
Participate in departmental initiatives
30% of travel required
Education and Experience
Bachelor degree
At least 6 years of experience in Clinical Operations
Skills and Qualifications
Has skills and expertise in oversight mentoring and coaching of CRAs
Independent professional who proactively communicates frequently and effectively.
Detail oriented organized and committed to quality and consistency
Excellent team-interaction skills and ability to work successfully in cross-functional teams
Ability to work in a dynamic environment with a high degree of flexibility
Physical Demands
While performing the duties of this job the employee is regularly required to sit reach with hands and arms and talk or hear. The employee must occasionally lift and/or move up to 15 pounds. Specific vision abilities required by this job include close vision and distance vision.
Work Environment
The noise level in the work environment is usually moderate.
If you come across a role that intrigues you but doesnt 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 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 . 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.
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: data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Required Experience:
Manager
Employment Type
Full-Time
