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)