Global Trial Specialist

Working with UsChallenging. 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: Global Trial Specialist (GTS)Division: Research and DevelopmentFunctional Area DescriptionCrossing all therapeutic areas and research phases, the GTS collaborates with cross-functional global teams to execute assigned operational aspects of global clinical research studies, from protocol development to the final clinical study report.Position Summary / Objective

Operational Execution : 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.

Study Management Support : Provides support for management of study deliverables (e.g., timelines, study plans, documents) through collaboration with internal and external stakeholders.

Process/System Enhancements : Supports process/system enhancements related to GTS responsibilities/deliverables and manages compliance with various quality or compliance systems.

Cross-functional Participation : Participates on cross-functional study teams.

CRO/Vendor Oversight : Supports performance and quality oversight of Contract Research Organization (CRO) systems and/or vendors.

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

Position ResponsibilitiesResponsibilities 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:Study/Project Planning, Conduct, and Management

Active Contribution : Actively contributes during study meetings by providing updates related to GTS responsibilities/deliverables.

Operational Support : Provides support for operational processes and management of study tools/plans in support of the startup, maintenance, and closeout of studies.

Study Execution : Assists the GTM in driving study execution.

Issue and Risk Management : Identifies issues and risks, develops mitigations, and escalates appropriately.

Attribute and Milestone Management : Manages applicable attributes and milestones/drivers in CTMS.

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

Meeting Coordination : Coordinates various meetings (e.g., Investigator Meetings, Data Monitoring Committee Meetings, Study Steering Committee Meetings, Kick-off Meetings), as applicable.

Non-clinical Supplies Management : Manages the global setup of study-level non-clinical supplies, as applicable.

Regulatory Compliance : Develops, updates, and submits Transfer of Obligations to Regulatory Authorities, as applicable.

Report Generation and Management : Generates and manages reports and lists relative to assigned studies.

Communication Management : Manages study mail-groups/distributions and SharePoint/Study Directory updates.

Audit Participation : Participates in filing activities and any associated audits/audit responses.

Vendor and Payment Management : Manages vendors and site payment processing and tracking, as applicable.

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

Guidance Seeking : Seeks guidance to navigate undefined tasks, challenges, and study tools/resources.

Degree Requirements

Education : BA/BS in a relevant discipline strongly preferred.

Experience Requirements

Clinical Systems : Experience in the use of industry Clinical Trial Management Systems and Clinical Trial Master File Systems is preferred.

Clinical Research : Experience in Global Clinical Research or related work is a plus.

Key Competency RequirementsTechnical Competencies

Software Proficiency : Proficient in MS Office suites (Word, Excel, Outlook, OneNote).

Budget Knowledge : Basic knowledge of clinical research budgets, including processing, reporting, and tracking of vendor payments, is a plus.

Regulatory Knowledge : Knowledge of ICH/GCP and regulatory guidelines/directives.

Project Management : Basic understanding of project management and drug development is desired.

Management Competencies

Networking : Begins to network and foster relationships with key stakeholders across the study team.

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

Innovative Thinking : Displays a willingness to challenge the status quo and take risks.

Communication : Effective oral/written communication skills, ability to collaborate with key stakeholders and across the organization.

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 CareersWith 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 ProtocolBMS 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 [email protected] . 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.Company: Bristol-Myers SquibbReq Number: R1583217Updated: 2024-07-04 02:25:47.720 UTCLocation: Princeton-NJBristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.