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Bristol Myers Squibb

Senior Manager, Clinical Research

Posted 7 Days Ago
Be an Early Applicant
Remote
Hiring Remotely in Oe-Machi, Nishimurayama, Yamagata
Senior level
Remote
Hiring Remotely in Oe-Machi, Nishimurayama, Yamagata
Senior level
Lead and manage a cross-functional Clinical Operations unit in Japan, supervising CTMs, CRAs and support staff to ensure timely execution of Phase I-IV trials. Oversee resource allocation, study metrics, compliance with GCP/ICH, vendor and site relationships, audit/inspection readiness, CAPA implementation, hiring, performance management, and collaboration with local cross-functional stakeholders.
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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.

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 To lead and manage a cross functional Clinical Operations Unit, ensuring delivery of clinical operations effectiveness in RCO Japan.Duties/Responsibilities
  • Supervises and coordinates the work assignments and performance of Regional Clinical Operations staff inclusive of Clinical Trial Managers (CTMs), Outsourced Clinical Trial Managers (OCTMs), Clinical Research Associate (CRAs), Country Coordinator (CCs), Site Contract Leads (SCLs) and/or Trial Managers Late Development to ensure timely execution consistent with R&D and local research goals and priorities.
  • Demonstrates the ability to effectively communicate with and influence individuals at all levels of the organization including situations of conflict resolution, problem solving and crisis management.
  • Anticipates resource needs and provides workload evaluations and task assignments.
  • Allocates and assign study resources in alignment with R&D and local research goals and priorities.
  • Supervises clinical trial execution at country level including supervising study metrics and team performance.
  • Approves study fee funds and payments based on grant of authority
  • May propose and/or validate country study targets.
  • May support Health Authority inspection and pre-inspection activities.
  • May support audit preparation & Corrective Action / Preventative Action preparation for local related issues.
  • Ensure Study Corrective Action / Preventative Action (CAPA) implementation and ensure the necessary resources / tools are available.
  • Develops goals that are consistent with R&D and local research goals and priorities and takes necessary actions to ensure that goals are met.
  • Together with the RCO management tracks and manages performance metrics for Regional Clinical Operations staff.
  • Anticipates and initiates action in response to multiple/changing demands and project priorities placed on Regional Clinical Operations Unit.
  • Point of Contact for FSP staff within the country.
  • Managing the hiring, performance management and succession planning of staff.
  • Performing general and human resource administrative functions.
  • Participation in performance calibration and talent review meetings.
  • Ensuring collaboration and information sharing with local country cross functional stakeholders (Medical, GRS, GPV, Market Access, Commercial, Human Resources).
  • When managing all RCO staff in a given country, will represent RCO in local leadership discussions at the affiliate level and may be member of the local affiliate leadership team managed by the General Manager.
  • Ensure effective external partnerships with Study Sites, Investigators, Pharma Trade Associations, Ministry of Health and /or Heath Authorities as needed. Manage partnerships with critical accounts / sites.
(Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)
  • Stakeholders within Global Clinical Operations: BMS Local Medical, GRS, GPV, Market Access, Commercial Brand Teams, Human Resources, Legal, Local clinical trial sites
Reporting Relationship
  • Report to Direct Supervisor: Director of RCO Japan
Qualifications
  • Minimum of 5 years Pharmaceutical industry experience in Clinical Research or Medical Affairs.
  • Prior monitoring experience required.
  • Significant experience in the planning, conduct and management of clinical programs (Phase I-IV).
  • Demonstrated ability to drive project related activities.
  • Previous supervisory and/or leadership experience (i.e. participation in task force, initiative or cross functional team).
  • Previous resource allocation experience preferred.
  • 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.
  • 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.
  • Good verbal and written communication skills (both in English and local language).
  • Software that must be used independently and without assistance (Microsoft Suite, Clinical Trial Management Systems (CTMS)).
  • Bachelors or Masters degree required. Field of study within life sciences or equivalent
  • Domestic travel to clinical trial sites and International travel where required

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 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.

Supporting People with Disabilities

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 [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

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/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at [email protected]. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.

R1600977 : Senior Manager, Clinical Research

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