Bristol Myers Squibb (BMS) Hiring Global Trial Acceleration Associate – Clinical Research

Bristol Myers Squibb (BMS) is inviting applications for the position of Global Trial Acceleration Associate at its Hyderabad, Telangana location. This is a full-time opportunity for candidates with experience in clinical development, clinical trial operations, regulatory documentation, and study start-up activities.

The selected candidate will support global clinical trials through essential document management, regulatory submissions, country and site activation, clinical trial documentation, and coordination with internal and external stakeholders.

Job Details

Positions

Global Trial Acceleration Associate

The role focuses on centralized operational activities supporting global clinical trials, particularly clinical documentation, regulatory submissions, study start-up, site activation, and ongoing clinical trial maintenance.

Key Responsibilities

• Manage and execute centralized activities supporting global clinical trials.
• Coordinate clinical documentation activities throughout study start-up, maintenance, and close-out.
• Manage essential documents and ethical and regulatory submission-related activities.
• Develop collaborative relationships with clinical study sites, CROs, vendors, Country Trial Managers, and study teams.
• Initiate and manage start-up documentation activities for global clinical trials.
• Coordinate country and site activation, including document reviews and activation checklists.
• Review and update clinical trial systems, including CTMS and eTMF, to track document status.
• Support regulatory submissions and essential document collection, review, and approval.
• Coordinate certified translations of clinical study documents, including ICF, Protocol, and Investigator’s Brochure (IB).
• Support the preparation of pharmacy and Investigator Site Files.
• Maintain and track essential clinical trial documentation throughout all study phases.
• Coordinate country and site-level Informed Consent Form (ICF) adaptations.
• Review Site Monitoring Visit reports and coordinate issue escalation, resolution, and follow-up.
• Support Clinical Study Report (CSR) distribution.
• Assist with outsourcing activities, vendor coordination, and compliance with procurement and regulatory requirements.

Eligibility / Qualifications

Candidates applying for the BMS Global Trial Acceleration Associate position should meet the following requirements:

• Minimum bachelor’s degree in Legal, Life Sciences, Business Administration, or equivalent experience.
• Minimum 3 years of relevant clinical development and operational experience in pharmaceutical, biotechnology, CRO, or similar industries.
• Hands-on experience preparing, reviewing, and submitting regulatory documentation to IRBs/IECs and regulatory agencies.
• Experience preparing and reviewing clinical study start-up and activation documentation.
• Knowledge of ICH-GCP and applicable regulatory guidelines and directives.
• Understanding of the drug development process and pharmaceutical industry operations.

Preferred Qualifications:

• Advanced degree.
• At least 3 years of global site monitoring experience as a Clinical Research Associate (CRA), particularly report review experience.
• Therapeutic area expertise in Oncology, Cardiology, Hematology, Immunology, or related areas.

Required Skills

• Clinical Trial Documentation Management
• Clinical Study Start-up and Site Activation
• Regulatory Submissions
• ICH-GCP Guidelines
• CTMS and eTMF Systems
• Veeva Vault (preferred)
• Clinical Trial Operations
• Essential Document Management
• Stakeholder Management
• Regulatory and Ethical Compliance
• MS Office and SharePoint
• Analytical and Decision-Making Skills
• Time Management and Organizational Skills
• Written and Verbal English Communication
• Cross-functional Team Collaboration