Job Title: Global Trial Acceleration Associate
Location: Hyderabad, Telangana, India
Company: Bristol Myers Squibb (BMS)
Company Overview
Bristol Myers Squibb (BMS) is a global biopharmaceutical company dedicated to transforming patients’ lives through science. The company promotes a supportive, inclusive, and innovative work environment, offering employees opportunities to grow, thrive, and contribute to meaningful, life-changing work in healthcare and clinical research.
Job Overview
The Global Trial Acceleration Associate manages and executes centralized activities in support of global clinical trials with an emphasis on clinical documentation, regulatory submissions, and site activation. The role interacts with study teams, sites, CROs/vendors, Country Trial Managers (CTM), and other functional areas to ensure efficient study start-up, maintenance, and close-out.
Key Responsibilities
Clinical Trial Start-Up & Documentation
Initiate and manage start-up documentation for global clinical trials.
Submit potential investigators to CTSS for debarment review and track decisions.
Review and finalize country/site activation checklists and ensure site activation per global/local procedures.
Quality control of start-up activities as required.
Update and review clinical systems (CTMS, eTMF, or vendor systems) to report trial document status.
Arrange certified translation of study documents (e.g., ICF, Protocol, IB).
Coordinate or create study-specific materials (pharmacy files, Investigator Site Files) for site visits.
Act as a single point of contact for centralized study activities during start-up.
Document Management & Regulatory Support
Maintain, track, and submit essential documents throughout all trial phases.
Review and approve country/site-level documents.
Assist with CSR distribution and informed consent (ICF) adaptation/amendments.
Review site monitoring visit reports, escalate issues, and ensure resolution.
Create and manage standardized document templates, as applicable.
Stakeholder Management & Collaboration
Develop and maintain collaborative working relationships with study teams, sites, CROs/vendors, and CTMs.
Support outsourcing activities, ensuring compliance with regulatory standards, ethical practices, and BMS policies.
Communicate with study teams regarding centralized activities and document requirements.
Other Responsibilities
Perform additional duties as required to support clinical trials.
Qualifications & Experience
Bachelor’s degree in Legal, Life Sciences, Business Administration, or equivalent; advanced degree preferred.
Minimum 3 years of relevant clinical development and operational experience in Pharmaceutical, Biotech, CRO, or similar fields.
Prior experience in global site monitoring (Clinical Research Associate) and report review preferred.
Therapeutic area expertise (Oncology, Cardiology, Hematology, Immunology, etc.) is preferred.
Hands-on experience preparing, reviewing, and submitting regulatory documentation to IRB/IECs and Regulatory Agencies.
Knowledge of ICH/GCP and regulatory guidelines, understanding of drug development processes.
Strong organizational, time-management, analytical, and decision-making skills.
Proficiency in MS Office Suite, SharePoint, CTMS; Veeva Vault experience preferred.
Effective communication (written and oral) and ability to manage internal/external stakeholders.
Ability to work in cross-functional, multi-cultural teams within a matrix structure.
Adaptability to dynamic and complex work environments; capable of managing multiple priorities.
Work Environment & On-Site Requirements
Roles may be site-essential, site-by-design, field-based, or remote-by-design.
Site-essential: 100% on-site presence required.
Site-by-design: Hybrid work model with at least 50% on-site.
Field-based/remote-by-design: Ability to travel to customers, patients, or business partners as required.
Equal Opportunity & Safety
BMS is committed to diversity, inclusion, and reasonable workplace accommodations.
Covid-19 vaccination is strongly recommended.
Employment considered for qualified applicants regardless of arrest/conviction records, in accordance with applicable law.
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