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Bristolmyerssquibb

Principal Global Trial Associate

Bristolmyerssquibb
Hyderabad - TS - INPosted about 2 months agoDiscoveredMatch locked
Full time

About the role

At Bristol Myers Squibb, our employees often ask, "Who are you working for?" - a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

  • 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

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.

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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 driving study executionContributes 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 interdependence of tasks assigned.Participates, sets up agendas, and captures meeting minutes in study team meetings for assigned protocols.Supports study specific CSR appendices, as needed. Manages vendors and site payment processing and tracking.Lead assigned study closure/archival activities during study closure phase This role will report into a line manager within Global Trial Management. The GTA can potentially support any therapeutic areas and research phase and will collaborate with cross-functional global teams to execute assigned operational aspects of global clinical research studies from protocol development to final clinical study report. We hire for skills and capabilities, not just credentials - if this role excites you, but doesn't perfectly match your resume, we encourage you to apply anyway. How We Work Where you work matters - because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

Supporting People with Disabilities

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.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. For roles based in Los Angeles County only: 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: https://careers.bms.com/california-residents/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection . Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. If this posting is missing required information required by local law or incorrect, contact BMS at TAEnablement@bms.com with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account. R1604574 : Principal Global Trial Associate

Not included in the source posting: about the role, qualifications, benefits.

Skills

excelgcp

Who can apply

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