Global Trial Associate – Clinical Operations
Location: Hyderabad, Telangana, India
Experience Required: 2–4 Years
Job Type: Full-Time
Job ID: R1597939
About Bristol Myers Squibb (BMS)
Bristol Myers Squibb (BMS) is a global biopharmaceutical company committed to transforming patients’ lives through science™. BMS develops innovative therapies in oncology, immunology, cardiovascular, and other therapeutic areas. The company fosters a culture of collaboration, inclusion, and innovation, empowering employees to grow professionally while driving global impact in clinical research and patient care.
Position Overview
The Global Trial Associate (GTA) supports the execution and oversight of clinical trials in alignment with BMS global standards. This role ensures accurate documentation, regulatory compliance, and effective communication with study teams, clinical sites, and vendors.
The GTA works closely with the Global Trial Lead (GTL) and cross-functional teams to support study start-up, conduct, maintenance, and close-out activities, contributing to high-quality delivery of global clinical trials.
Key Responsibilities
Project & Study Management
Support Global Trial Lead using performance metrics and quality indicators to drive study execution.
Resolve routine study issues and escalate critical matters as needed.
Participate actively as a key member on cross-functional study teams.
Study Planning & Execution
Maintain understanding of study tools, plans, and timelines.
Manage study documentation, eTMF accuracy, and study-level updates on SharePoint and CTMS.
Support vendor management, including invoice review, accruals, and scope of work adjustments.
Assist in startup, maintenance, and close-out activities for assigned studies.
Facilitate creation and tracking of study-specific materials, such as Informed Consent documents and regulatory submissions.
Operational Oversight & Reporting
Monitor study progress, update global site lists, and manage communications with sites and vendors.
Participate in meetings, capture minutes, and support documentation of study activities.
Identify risks, develop mitigations, and escalate issues appropriately.
Assist with CSR appendices and study closure/archival activities.
Collaboration & Compliance
Ensure adherence to ICH/GCP guidelines and regulatory standards.
Support global study processes while collaborating effectively with multi-cultural and cross-functional teams.
Follow BMS policies for documentation, regulatory submission, and vendor management.
Required Qualifications & Skills
Education: BA/BS or Associate degree in Life Sciences, Clinical Research, or related discipline.
Experience: 2–4 years in clinical research, clinical operations, or related pharmaceutical/CRO experience.
Technical Knowledge: Proficiency with CTMS, eTMF, clinical documentation, and trial tracking tools. Veeva Vault experience is a plus.
Regulatory Knowledge: Understanding of GCP/ICH guidelines and clinical trial regulatory requirements.
Project Skills: Basic project management knowledge, operational planning, and documentation oversight.
Communication & Collaboration: Strong verbal and written communication skills; ability to work effectively with cross-functional and multi-cultural teams.
Adaptability: Ability to handle multiple priorities, learn quickly, and escalate issues as appropriate.
Why Join BMS
Engage in global clinical trials that advance innovative therapies.
Work in a collaborative and inclusive culture that values your expertise.
Gain exposure to multi-functional clinical operations and regulatory processes.
Contribute to process improvement and quality delivery across clinical trial activities.
Equal Opportunity & Accessibility
BMS is committed to diversity, equity, and inclusion. Applicants with disabilities may request reasonable accommodations during the recruitment process. The application process is secure and transparent; BMS will never request payments or financial information.
Apply Now to join a team that drives global clinical trial success and transformative patient outcomes.
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