PHARMAFull-time
Global Trial Acceleration Associate
HYDERABAD (IN)ONSITEPOSTED: 8/25/2026
PHARMAFull-time
HIRING ORGANIZATIONBRISTOL MYERS SQUIBBPharmaceuticals
BR
ROLE DEFINITION & RESPONSIBILITIES
Role & Organizational Overview
The Global Trial Acceleration Associate is an individual contributor role within Clinical Operations at Bristol Myers Squibb (BMS) in Hyderabad. Operating within a site-by-design or onsite model, this position manages centralized operational tasks supporting global clinical trials across all phases (I-IV), focusing heavily on essential trial documentation, site monitoring report reviews, and regulatory start-up activities.
Core Responsibilities
Essential Document Management: Collect, compile, review, and approve country and site-level essential documents throughout the trial lifecycle (start-up, maintenance, and close-out) in compliance with ICH-GCP.
Site Activation & Start-Up: Manage start-up documentation workflows, perform investigator debarment checks via CTSS, review site activation checklists, and execute final site activation sign-offs.
Site Monitoring Visit Report Review: Centrally review Site Monitoring Visit reports, identify potential operational issues, manage escalations, and track corrective action follow-ups.
System Maintenance & Quality Control: Maintain and audit clinical systems including CTMS and eTMF. Ensure audit readiness and execute quality control checks on trial deliverables.
Cross-Functional & Vendor Support: Interact with CROs, clinical study sites, Country Trial Managers (CTM), and internal study teams. Assist with ICF adaptations, certified translations, study-specific file creation (Pharmacy/ISF), and Clinical Study Report (CSR) distributions.
Technical & Domain Standards
Compliance with Good Clinical Practice (GCP), ICH guidelines, and global regulatory submission requirements.
Hands-on execution of trial administration tools including CTMS, eTMF, and CTSS platforms.
Maintenance of trial master file documentation integrity and 100% inspection-readiness.
Leadership & Business Impact
Serves as a centralized operational focal point, reducing trial activation timelines, ensuring compliance across trial sites, and accelerating the execution of global clinical studies for BMS.
REQUIRED VERIFIED SKILLS
Clinical Trial Management
eTMF
CTMS
ICH-GCP
Essential Documents
Site Activation
Site Monitoring Report Review
Trial Start-Up
Regulatory Submissions
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
ORGANIZATION CONTEXT & CULTURE
Bristol Myers Squibb is actively hiring for this position.
INDUSTRY: Pharmaceuticals
RECOMMENDED TRAINING
1/5
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