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Job Description
Location: Hyderabad, Telangana, India
Job Requisition ID: Not Specified
Job Category: Clinical Development / Clinical Operations
Job Type: Full-Time
About the Role
Bristol Myers Squibb (BMS) is seeking a Global Trial Acceleration Associate to join its Clinical Operations team. This role is central to supporting global clinical trials through the management of essential documentation, ethical and regulatory submissions, and site activation activities. The successful candidate will collaborate with study teams, CROs, vendors, and regulatory stakeholders to ensure compliance, timely trial execution, and high-quality data delivery.
At BMS, you’ll find work that is challenging, meaningful, and life-changing. With a single vision — Transforming patients’ lives through science™ — every employee contributes to a mission that extends far beyond ordinary careers.
Role & Responsibilities
- Manage and execute centralized activities in support of global clinical trials, with emphasis on clinical documentation.
- Act as the main point of contact for essential document management, regulatory submissions, and ethical approval activities.
- Support outsourcing activities, including vendor selection, contracting, and execution of outsourced studies, ensuring compliance with regulatory and ethical standards.
- Initiate and manage start-up documentation activities for global trials.
- Submit potential investigators to CTSS for debarment review and track decisions.
- Oversee country and site activation processes, including checklist sign-off and document verification.
- Conduct quality control reviews of start-up activities and study documents.
- Update and review clinical trial systems (CTMS, eTMF, Veeva Vault, etc.) to track documentation status.
- Coordinate certified translations of study-level documentation as required.
- Assist in preparation of study-specific materials such as pharmacy manuals or investigator site files.
- Collect, review, and approve essential country and site-level documents during all trial phases.
- Centrally review Site Monitoring Visit reports, escalate issues, and track resolutions.
- Create and manage standardized document templates and support CSR distribution.
- Provide ongoing communication with study teams regarding centralized study activities.
Educational Qualification
ucation & Qualifications
- Bachelor’s degree in Life Sciences, Legal, Business Administration, or equivalent (Advanced degree a plus).
Experience & Skills
- Minimum 3 years of clinical development and operational experience in pharmaceutical, biotech, or CRO environments.
- Field monitoring experience with at least 3+ years of global site monitoring/report review preferred.
- Hands-on experience with regulatory submissions to IRBs/IECs and regulatory agencies.
- Proven experience in preparing, reviewing, and submitting study start-up and activation documentation.
- Strong knowledge of ICH/GCP guidelines and regulatory requirements.
- Proficiency in CTMS, eTMF, Veeva Vault, MS Office, SharePoint, and clinical trial enabling technologies.
- Prior therapeutic area expertise (Oncology, Cardiology, Hematology, Immunology, etc.) preferred.
- Strong organizational, time-management, and analytical skills.
Location
Hyderabad, Telangana, India
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