Global Trial Associate (GTA)
Location: Hyderabad, Telangana, India
Job ID: R1594651
Company: Bristol Myers Squibb
Role Summary
The Global Trial Associate (GTA) provides operational and administrative support for the planning, execution, maintenance, and closeout of global clinical trials. Working closely with the Global Trial Manager (GTM) and cross-functional teams, the GTA ensures smooth study operations, supports regulatory activities, manages study documentation, coordinates vendor-related processes, and contributes to the successful delivery of clinical research programs.
Key Responsibilities
Clinical Trial Operations
Support study startup, conduct, maintenance, and closeout activities.
Assist the Global Trial Manager (GTM) in driving study execution and operational deliverables.
Participate in study-level planning and execution activities.
Provide operational support for assigned clinical studies.
Learn and perform core Global Trial Services (GTS) responsibilities while escalating issues appropriately.
Regulatory & Study Management Support
Support responses to country regulatory authorities and IRB/IEC requests.
Develop, maintain, and submit Transfer of Obligations documentation to Regulatory Authorities.
Assist with study-related regulatory documentation and compliance activities.
Ensure adherence to ICH-GCP guidelines and applicable regulatory requirements.
Vendor & Financial Management
Coordinate vendor setup and onboarding activities.
Facilitate vendor payment processing with relevant stakeholders.
Maintain and manage global vendor site lists.
Resolve vendor-related operational issues.
Support tracking and reporting of vendor payments and study budgets.
Documentation & Systems Management
Manage study distribution lists, mail groups, and communication channels.
Maintain SharePoint sites and study directories.
Support filing activities and Trial Master File (TMF) maintenance.
Participate in audits and inspection-readiness activities.
Ensure study documentation is accurate, complete, and up to date.
Risk & Issue Management
Identify operational risks and study issues.
Develop mitigation strategies and escalate concerns when necessary.
Monitor study activities and proactively communicate potential challenges.
Support issue resolution and continuous study oversight.
Meeting & Stakeholder Coordination
Organize study team meetings and prepare agendas.
Capture and distribute meeting minutes and action items.
Collaborate with cross-functional teams and stakeholders.
Build productive relationships across study teams and support functions.
Required Qualifications
Education
Bachelor's Degree (BA/BS) or Associate Degree in:
Life Sciences
Pharmacy
Biotechnology
Clinical Research
Nursing
Healthcare
Related Scientific Discipline
Experience
Experience in Clinical Research, Clinical Operations, or related healthcare field.
3+ years of experience using Clinical Trial Management Systems (CTMS) and Clinical Trial Master File (CTMF/eTMF) systems preferred.
Exposure to global clinical trials and multinational study environments preferred.
Experience supporting study management activities is advantageous.a
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