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Senior Global Trial Associate

Bristol-Myers Squibb

Hyderabad - TS - INMidH-1B sponsor company
Sign in to applyVerified 1h ago
Location
Hyderabad - TS - IN
Work model
On-Site
Level
Mid
H-1B history
57 approvals (FY2023)
Posted
10h ago

Skills

GCP

About this role

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: careers.bms.com/working-with-us . 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  undefined 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/implements 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. undefined Study/Project Planning, Conduct and Management Provides 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

Senior Global Trial Associate at Bristol-Myers Squibb, Hyderabad - TS - IN | Yoinka