Chef(fe) principal(e), Opérations cliniques / Senior Manager Clinical Opera

at  BristolMyers 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 rich in diversity. 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 .

JOB SUMMARY

Lead and manage a Clinical Operations Unit team that may be cross - functional , ensuring delivery of clinical operations effectiveness in RCO Canada

Key Responsibilities and Major Duties

• Supervises and coordinates the work assignments and performance of Clinical Operations staff that may be inclusive of Clinical Trial Managers (CTMs), Clinical Trial Monitors (CTMos), Clinical Trial Associates (CTAs), Study Start-up Specialists (SSUSs) and/or Site Contract Leads (SCLs) 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 for assigned studies and teamincluding supervising study metrics and team performance
• Proactively identifies and escalates risks/gaps in BMS process
• May 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
• E nsure Study Corrective Action / Preventative Action (CAPA) implementation and ensure the necessary resources / tools are available
• With local management, 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 assigned FSP staff within the country
• Managing the hiring, performance management and succession planning of direct reports
• Performing general and human resource administrative functions
• Participation in performance calibration and talent review meetings
• Ensur es collaboration and information sharing with local country cross functional stakeholders (Medical, GRS, GPV, Market Access, Commercial, Human Resources)
• Contributes to effective external partnerships with Study Sites, Investigators, Pharma Trade Associations, Ministry of Health and /or Heath Authorities as needed
• Manages/oversees partnerships with critical accounts / sites for assigned studies and therapeutic areas

Qualification & Experience

• Bachelors required preferably within life sciences or equivalent 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-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
• Experience mentoring and providing feedback to others 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).
• Travel requirement: Occasional Domestic travel /international travel as required

Why You Should Apply

• 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
• We invite you to forward your resume online and we will be happy to contact you if your candidacy is selected for an interview

• Supervises and coordinates the work assignments and performance of Clinical Operations staff that may be inclusive of Clinical Trial Managers (CTMs), Clinical Trial Monitors (CTMos), Clinical Trial Associates (CTAs), Study Start-up Specialists (SSUSs) and/or Site Contract Leads (SCLs) 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 for assigned studies and teamincluding supervising study metrics and team performance
• Proactively identifies and escalates risks/gaps in BMS process
• May 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
• E nsure Study Corrective Action / Preventative Action (CAPA) implementation and ensure the necessary resources / tools are available
• With local management, 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 assigned FSP staff within the country
• Managing the hiring, performance management and succession planning of direct reports
• Performing general and human resource administrative functions
• Participation in performance calibration and talent review meetings
• Ensur es collaboration and information sharing with local country cross functional stakeholders (Medical, GRS, GPV, Market Access, Commercial, Human Resources)
• Contributes to effective external partnerships with Study Sites, Investigators, Pharma Trade Associations, Ministry of Health and /or Heath Authorities as needed
• Manages/oversees partnerships with critical accounts / sites for assigned studies and therapeutic area