Principal Global Trial Associate

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.

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• Contributes to the operational execution of clinical 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.

• Provides operational input on development, management and maintenance of study deliverables (i.e. timelines, study plans, documents, etc.) through collaboration with internal and external stakeholders.

• Primarily works on routine to complex projects/trials at varying stages and supports multiple complex trials as needed.

• Contributes to achieving corporate and study team goals, successfully completes assigned tasks, participates in service provider oversight, and sets priorities with guidance.

• Manages the development and/or collection of study level documentation and support Global Trial Lead (GTL) in ensuring eTMF accuracy and completion for all studies.

• Proactively manages multiple assignments and operational processes with moderate to minimal supervision.

• Manages country planning, protocol level attributes and milestones/drivers in CTMS.

• Has high functional impact on the study team and the organization.

• Support Global Trial Lead (GTL) in tracking of non-clinical supplies

• Support Global Trial Lead (GTL) in vendor management related activities

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

Responsibilities involve a combination of execution and oversight, dependent on the sourcing model, to ensure deliverables and may include, but are not limited to the following:

Project Management

• Manages the development and/or collection of study level documentation & support Global Trial Lead (GTL) in ensuring eTMF accuracy & completion of for all studies

• Provides operational input and facilitates operational processes as an SME in support of the startup, maintenance, and closure of studies.

• Uses performance metrics and quality indicators to assist the Global Trial Lead (GTL) in driving study execution.

• Proactively Identifies risks and develops/implement action to avoid or mitigate.

• Resolves routine problems and escalates important issues appropriately (with a sense of urgency).

• Actively contributes as a key functional member on cross-functional teams.

• Study/Project Planning, Conduct and ManagementProvides and support input to study level tools and plans while working with moderate to minimal supervision, including but not limited to the Transfer of Obligations to Regulatory authorities. Study Sharepoint/study directory updates and the Global Vendor Site List etc.Independently performs core Global Trial Associate (GTA) tasks and escalates/pushes back/delegates appropriately.Simple studies or studies in closure phase may be managed in alignment with OPL or GTL.Reviews vendor invoices and lead approval process or submits to GTL's for approval (as needed); manages accruals and LSD/SOW changesActively contributes to study meetings by leading assigned topics/components.Assist the Global Trial Lead (GTL) in driving study executionContributes to oversight of the required country regulatory (e.g., CTA, MoH) and country/site IRB/IEC approvals/notifications.Flexibility to work on various trials at varying stages/complexity with minimal guidance as needed.Understands strategy and decision making at program level and their impact on the studies.Ability to contribute to initiatives for process development and improvement.Ability to assess a situation and identify path forward with the appropriate resources.Understands interdependence of tasks assigned.Participates, sets up agendas, and captures meeting minutes in study team meetings for assigned protocols.Supports study specific CSR appendices, as needed. Manages vendors and site payment processing and tracking.Lead assigned study closure/archival activities during study closure phase

This role will report into a line manager within Global Trial Management. The GTA can potentially support any therapeutic areas and research phase and will collaborate with cross-functional global teams to execute assigned operational aspects of global clinical research studies from protocol development to final clinical study report.

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 adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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R1604574 : Principal Global Trial Associate