Sr. Global Trial Manager

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 Title:
Senior Global Trial Manager

Division:
Research and Development

Functional Area Description:
Global Trial Managers, across all therapeutic areas and research phases, collaborate with cross-functional teams to drive operational aspects of complex, global clinical research studies from concept to final clinical study report.

Position Summary:

• Provides strategic and operational leadership of clinical research studies to ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP, Regulatory Authorities' regulations/guidelines, and applicable SOPs/WPs.
• Independently leads complex, large, global in-house or outsourced, Non-Registrational Data Generating or Registrational Data Generating trials/studies at any point in the life cycle of the trial/study (i.e., start-up, maintenance, or close-out).
• Acts as the primary operational contact for the study and leads the cross-functional global team for execution of the study.
• May provide operational leadership of one or more cross-functional Study Team(s) and/or performance and quality oversight of one or more Contract Research Organization (CRO) teams and vendors.
• Has high global organizational impact and influence, and significant impact on function and Study Team.

Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be assigned as required.

Position Responsibilities:

Project Management:

• Directs and delegates to the assigned Global Trial Management Staff as applicable.
• Drives study execution utilizing available performance metrics, quality indicators, study milestones, and drivers.
• Oversees clinical monitoring quality and adherence to established processes and plans.
• Develops, manages, and maintains study deliverables (i.e., timelines, study plans, etc.) through collaboration with internal and external stakeholders using data and strong interpersonal influencing skills to make robust data-driven decisions.
• Proactively identifies potential risks and develops/implements actions to avoid/mitigate and make appropriate trade-offs of balancing risks with study deliverables and costs.
• Maintains/updates data as appropriate in project management tools including CTMS.
• Troubleshoots complex issues with little guidance and support.
• Informs operational program lead(s) and other leadership (as appropriate) on overall clinical trial plans, recruitment status, and raises potential issues/mitigation.
• Leads, develops, and implements cross-functional/global initiatives and best practices.
• Creates, maintains, and implements project management tools at the study level (e.g., actions, decisions, issues log, and risk management plan).

Study Planning and Conduct:

• Supports and oversees country and site feasibility/selection processes with use of robust data.
• Provides operational and strategic input into Study Team and study documents.
• Collaborates with CSO on global investigational product (IP) supply forecasting/management.
• Participates in the subject recruitment/retention strategy and related initiatives (e.g., recruitment material).
• Participates in clinical service provider (vendor) selection, specification development, and management/oversight.
• Oversees TMF set-up, ongoing quality review, operational oversight memo, and requests final reconciliation.
• Provides input to and reviews study training for Study Team, investigational sites, and vendors in collaboration with the Clinical Scientist.
• Over