Senior Global Trial Specialist

Bristol-Myers Squibb Company

Ts, IN

Working with Us
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Job Title

Phase IV Senior Global Trial Specialist


Research and Development

Functional Area Description

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

Position Summary

• 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.

• Participates on 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.

• 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.

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

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

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

Position Responsibilities

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 in operational processes as a SME in support of the startup maintenance and close out of studies.

• Uses performance metrics and quality indicators to assist the Global Trial Manager in driving study execution.

• Proactively identifies potential risks and develops/implements actions to avoid or mitigate.

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

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

Study/Project Planning, Conduct and Management

• Provides and support input to study level tools and plans while working with moderate to minimal supervision.

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

• Actively contributes to study meetings by leading some components.

• Contributes 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 interdependencies of tasks assigned.

• Manages vendors and site payment processing and tracking.

• Facilitate the maintenance of study budget tracking tools and reconciles invoices with overall contract/budget and finance reports.

Degree Requirements

BA/BS or equivalent degree in relevant discipline

Experience Requirements

• Minimum 1 year experience in Clinical Research or related work experience.

• Experience in the use of industry Clinical Trial Management Systems and Clinical Trial Master File Systems.

• Global experience is required.

Key Competency Requirements

Technical Competencies

• Knowledge of ICH/GCP, regulatory guidelines and directives, and the drug development process.

• Knowledge of clinical research budgets including processing and tracking of site and vendor payments is preferred.

• Working knowledge of project management preferred.

Management Competencies

• Begin to network and foster relationships with key stakeholders across the study team.

• Responds flexibly to changing business demands and opportunities, proactively looking for ways to contribute.

• Acts as a role model in supporting change within the organization and has knowledge of cross-functional partners who can help clarify change.

• Mentors and coaches other team members and GTS’, as appropriate, and participate or provide leadership in departmental initiatives.

• Builds relationships to achieve influence with others.

• Develops and maintains collaborative relationships with internal and external stakeholders to be more effective in the role.

• Displays a willingness to challenge the status quo and take risks

• Effective oral and written communication skills, ability to across the matrix, organization, and to key stakeholders

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 Visit 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.

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