Global Trial Acceleration Associate

Bristol Myers Squibb

Hyderabad, IN, United States
50% onsite
Clinical trial document collection and review
Site monitoring visit report review
Regulatory submission activities
This individual contributor role has task-level responsibility for clinical trial related document collection, compilation, review and approval across all phases of global clinical trials

Job Summary

  • This individual contributor role has task-level responsibility for clinical trial related document collection, compilation, review and approval across all phases of global clinical trials.
  • The Global Trial Acceleration Associate will interact with clinical study sites, CROs/vendors, Country Trial Managers (CTM)/Clinical Trial Monitor (CTMo.), the study team and other functional areas within BMS and will provide support to the Study Team throughout the study duration.
  • Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment and offers a wide variety of competitive benefits, services and programs.

Matching Summary

This individual contributor role has task-level responsibility for clinical trial related document collection, compilation, review and approval across all phases of global clinical trials.

Skills & Requirements

Must-have

  • Clinical trial document collection and review
  • Site monitoring visit report review
  • Regulatory submission activities
  • ICH/GCP knowledge
  • Clinical study start-up documentation

Nice-to-have

  • Cross-functional team collaboration
  • Adaptability in complex environments
  • Patient-focused work culture
  • Promoting diversity in clinical trials

Key Requirements

  • Bachelor's degree in legal, Life science, Business Administration, or equivalent experience
  • Minimum 3 years of relevant clinical development & operational experience
  • Seasoned field monitor with min 3+ years of global site monitoring report review experience preferred
  • Prior therapeutic area expertise preferred
  • Hands-on experience preparing, reviewing, and submitting regulatory documentation
  • Hands-on experience preparing, reviewing, and submitting clinical study start-up / activation documentation
  • Effective communication skills in English (written & oral)
  • MS office suite, SharePoint, CTMS (Veeva Vault experience preferred)

Work Rights

Not specified

Tailored Resume

Cover Letter