Global Trial Specialist

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 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 Job Title Global Trial Specialist Division 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 Objective Contributes to the operational execution of clinical studies and supports complex global trials as needed 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 Drives process system enhancements related to GTS responsibilities deliverables and manage comply with various quality or compliance systems Manages country planning protocol level attributes and milestones drivers in CTMS Manages the development and or collection of study level documentation support GTM in ensuring eTMF accuracy and completion for all studies Manages the global setup of study level non-clinical supplies 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 Study Project Planning Conduct and Management Understands study level tools and plans Provides support to the GTM along with the appropriate teams for response to country regulatory and IRB IEC Provides operational input and participates in operational processes in support of the startup maintenance and close out of studies Assist the GTM in driving study execution Learns observes and performs core GTS tasks and escalates appropriately Facilitates vendor creation and payment processing in conjunction with the appropriate stakeholders Raises possible issues for potential escalation to the appropriate colleagues Follows instructions determines level of understanding and seeks clarification when needed Seeks guidance to navigate undefined tasks challenges and study tools resources Develops updates and submits Transfer of Obligations to Regulatory Authorities Manages global vendor site lists and resolve issues related to global site lists Manages study mail-groups distributions and SharePoint Study Directory updates Participates sets up agendas and captures meeting minutes in study team meetings for assigned protocols Identifies issues and risks develops mitigations and escalates appropriately Participates in filing activities and any associated audits as applicable Degree Requirements BA BS or Associate degrees in relevant discipline Experience Requirements Experience in the use of industry Clinical Trial Management Systems and Clinical Trial Master File Systems is a plus Experience in Clinical Research or related work experience Global experience is a plus Key Competency Requirements Technical Competencies Basic knowledge of clinical research budgets including processing and tracking of site and vendor payments is preferred Knowledge of ICH GCP and regulatory guidelines directives Basic understanding of project management desired 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 Displays a willingness to challenge the status quo and take risks Effective oral and written communication skills ability to influence cross-functionally demonstration of leadership capabilities Travel Required Less than 5 Describe Exposure to Any Hazards Disagreeable Conditions in the Work Environment N A 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 TM 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 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 If you live in or expect to work from Los Angeles County if hired for this position please visit this page for important additional information Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations