PHARMAFull-time
Principal Global Trial Associate
HYDERABAD (IN)ONSITEPOSTED: 8/25/2026
PHARMAFull-time
HIRING ORGANIZATIONBRISTOL MYERS SQUIBBPharmaceuticals
BR
ROLE DEFINITION & RESPONSIBILITIES
Role & Organizational Overview
The Principal Global Trial Associate at Bristol Myers Squibb (BMS) in Hyderabad is a senior operational role within Global Trial Management. Reporting to a Line Manager, this position provides expert operational execution and leadership across complex, global clinical trials across all research phases and therapeutic areas from study start-up through final Clinical Study Report (CSR) completion and archival.
Core Responsibilities
Study Execution & Project Management: Collaborate with the Global Trial Lead (GTL) to manage study deliverables, track operational milestones, and maintain timelines and study plans in compliance with ICH/GCP standards and global SOPs.
eTMF & Documentation Management: Direct the collection and development of study-level documentation. Ensure 100% accuracy, completeness, and audit-readiness of the Trial Master File (eTMF) across assigned global protocols.
CTMS & Country Planning: Oversee country planning, protocol-level attributes, non-clinical supply tracking, and milestone drivers within CTMS. Manage global site lists, study directories, and Transfer of Obligations tracking.
Vendor & Financial Governance: Assist with service provider oversight, manage vendor site payment processing, perform invoice reviews, track financial accruals, and support Scope of Work (SOW) modifications.
Risk Mitigation & Trial Closure: Proactively identify operational risks, formulate mitigation strategies, lead study team agendas and meeting components, and direct end-to-end study closure and archiving activities.
Technical & Domain Standards
Mastery of ICH/GCP regulations, regulatory submission workflows (CTA, MoH, IRB/IEC approvals), and clinical trial SOPs.
Advanced operational utilization of eTMF systems, CTMS, and vendor management platforms.
Complete execution of CSR appendices management, clinical financial tracking, and vendor oversight.
Leadership & Business Impact
Functions as a Subject Matter Expert (SME) on cross-functional study teams, driving critical path execution, resolving complex trial bottlenecks with minimal supervision, and mentoring junior trial associates.
REQUIRED VERIFIED SKILLS
Clinical Trial Management
eTMF
CTMS
ICH-GCP
Vendor Management
Risk Management
Trial Start-Up
Study Archival
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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