Job Details

Senior Global Trial Specialist

Clinical Development

icon-location-marker Princeton - NJ - US
Posted 17 days ago Full_time R1583355

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.

Crossing all therapeutic areas and research phases, collaborate with cross-functional global teams to execute assigned operational aspects of global clinical research studies from protocol development to final clinical study report.

  • Functions as a Mentor and key resource for GTS team members.
  • Acts as a Subject Matter Expert (SME) for applicable systems/processes.
  • Contributes to the operational execution of clinical studies at various stages to ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP and applicable SOPs.
  • Provides support for management of study deliverables (i.e., timelines, study plans, documents, etc.) through collaboration with internal and external stakeholders. 
  • Drives process/system enhancements related to GTS responsibilities/deliverables and manages/complies with various quality or compliance systems.

•     Participates on cross-functional study teams.

  • Supports performance and quality oversight of Contract Research Organization (CRO) teams and/or vendors. 

•    Contributes to the achievement of corporate and study team goals, successfully completes assigned tasks and sets priorities with guidance. 

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

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

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 

  • 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 Manager in driving study execution. 
  • In collaboration with the study team, identifies risks and develops/implements actions to avoid or mitigate possible issues when appropriate. 
  • 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 Management

•     Independently performs core GTS tasks and escalates/pushes back/delegates when appropriate. 

•     Actively contributes during study meetings by providing updates related to GTS responsibilities/deliverables.

  • Provides support for operational processes and management of study tools/plans in support of the startup, maintenance and close out of studies
  • Assist the GTM in driving study execution.

•     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 interdependencies of tasks assigned. 

  • Manages applicable attributes and milestones/drivers in CTMS.

•     Manages the development and/or collection of applicable documentation, supports GTM in ensuring eTMF accuracy and completion for all studies.

  • Coordinates various meetings (Inv Mtgs, Data Monitoring Committee Mtgs, Study Steering Committee Mtgs, Kick-off Mtgs), as applicable.    
  • As applicable, manages the global setup of study level non-clinical supplies.
  • As applicable, develops, updates, and submits Transfer of Obligations to Regulatory Authorities.
  • Generates and manages reports and lists relative to the assigned studies
  • Manages study mail-groups/distributions and SharePoint/Study Directory updates.
  • Participates in filing activities and any associated audits/audit responses.

•    Manages vendors and site payment processing and tracking, as applicable. 

•    Facilitates the maintenance of study budget tracking tools and reconciles invoices with overall contract/budget and finance reports, as applicable. 

•     BA/BS in relevant discipline strongly preferred

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 an inclusive culture, promoting diversity 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 a diverse 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.

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.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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