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Position Summary / Objective:
Regional Clinical Operations (RCO) United States of America, R&D regional organization responsible for the execution of phase I-IV clinical studies in United States of America. To lead and manage a cross functional Clinical Operations Unit, ensuring delivery of clinical operations effectiveness in RCO United States of America.
Key Responsibilities and Major Duties:
Supervises and coordinates the work assignments and performance of Clinical Operations staff inclusive of Clinical Trial Managers (CT Mgrs), Clinical Trial Monitors (CTMs), Clinical Trial Associates (CTAs), Site Relationship Managers, Study Start-up Specialists and/or Site Contract Leads 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 Clinical Operations staff
Anticipates and initiates action in response to multiple/changing demands and project priorities placed on 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 Supervisory Responsibility (List job titles of positions that report directly or indirectly to this position and indicate nature of relationship)Direct line reporting responsibility for CT Mgrs, CTMs, CTAs, Site Relationship Managers, Study Start-up Specialist and Site Contract Lead roles
RCO United States of America
Stakeholders within Global Clinical Operations
BMS Local Medical, GRS, GPV, Market Access, Commercial Brand Teams, Human Resources, Legal, Local clinical trial sites
(Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)
Minimum of 5 years Pharmaceutical industry experience in Clinical Research or Medical Affairs
For CT Monitor Line Managers - Prior monitoring experience required
Significant experience in the planning, conduct and management of clinical programs (Phase I-I V)
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
Key Competency Requirements:
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)
Clinical Trial Management Systems
Domestic travel to clinical trial sites
International travel where required
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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.
Bristol Myers Squibb