Location: Hyderabad, Telangana, India
Company: Bristol Myers Squibb
Job ID: R1599963
Work Model: Hybrid / Site-Based
Experience Required: Minimum 3+ years (Not suitable for freshers)
About the Company
Bristol Myers Squibb is a leading global biopharmaceutical organization driven by a mission to transform patients’ lives through science. The company operates at the forefront of innovation across therapeutic areas such as oncology, hematology, immunology, and cardiovascular diseases. With a strong emphasis on scientific excellence and patient-centricity, BMS offers professionals the opportunity to work on high-impact global clinical trials.
Job Overview
The Global Trial Acceleration Associate is a critical individual contributor role responsible for managing clinical trial documentation, regulatory coordination, and centralized operational activities across all phases of global clinical studies. This role ensures seamless execution of trial start-up, maintenance, and close-out activities while maintaining compliance with global regulatory standards.
Key Responsibilities
Manage and execute centralized clinical trial documentation and operational activities across global studies
Act as the primary point of contact for document management, regulatory submissions, and study coordination
Collaborate with study teams, CROs, vendors, and clinical sites to ensure timely trial execution
Initiate, track, and manage start-up documentation and site activation processes
Perform review and quality checks of essential clinical documents and regulatory submissions
Monitor and review Site Monitoring Visit (SMV) reports, escalate issues, and ensure timely resolution
Maintain and update clinical trial systems such as CTMS and eTMF for document tracking and compliance
Support outsourcing activities including vendor coordination, contracting, and compliance oversight
Assist in preparation and management of study materials such as Investigator Site Files and pharmacy documentation
Coordinate translation and adaptation of study documents including ICF, protocols, and Investigator Brochures
Ensure continuous communication with study teams regarding document status and trial progress
Contribute to CSR distribution and country/site-level documentation management
Eligibility Criteria
Bachelor’s degree in Life Sciences, Pharmacy, Clinical Research, Business Administration, or related field
Minimum 3+ years of experience in clinical trials, clinical operations, or regulatory documentation
Prior experience in global clinical trial start-up, site activation, or document management is highly preferred
Experience as a Clinical Research Associate (CRA) with monitoring/report review exposure is advantageous
Strong understanding of ICH-GCP guidelines, regulatory frameworks, and drug development lifecycle
Hands-on experience with CTMS, eTMF, Veeva Vault, or similar clinical systems
Excellent communication, stakeholder management, and cross-functional collaboration skills
Ability to manage multiple priorities in a fast-paced, global clinical environment
Preferred Skills
Exposure to therapeutic areas such as Oncology, Immunology, Cardiology, or Hematology
Experience in regulatory submissions to IRB/IEC and global health authorities
Strong analytical mindset with attention to detail and compliance standards
Ability to work in matrix teams across geographies
Work Environment & Culture
Hybrid working model with required on-site collaboration
Opportunity to work with global cross-functional teams
Inclusive, innovation-driven culture focused on career growth and scientific advancement
Exposure to large-scale, high-impact clinical trials
Important Note for Applicants
This is an experienced-level role requiring hands-on exposure to clinical trial operations and documentation. Freshers are advised to begin with entry-level roles such as Clinical Trial Assistant (CTA), Drug Safety Associate, or Clinical Research Coordinator before progressing to such global roles.
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