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Senior Global Trial Associate

Bristol Myers Squibb
2-4 years
INR 15-22 LPA
Hyderabad
10 June 15, 2026
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Clinical Trials, Detail-Oriented, Drug Development, Lifesciences, Negotiation Skills, Regulatory Compliance, Communication Skills, CPC Certified, Data Analysis, Document Management, Life Science, Regulatory Compliance, Waterfall Model, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing

Position Summary

The Global Trial Associate (GTA) supports the operational execution of global clinical studies to ensure delivery:

  • On time

  • Within budget

  • With high quality standards

  • In compliance with ICH-GCP guidelines, regulatory requirements, and company SOPs

The role works closely with the Global Trial Lead (GTL), study teams, vendors, and cross-functional stakeholders to support clinical trials from study start-up through study closure.


Key Responsibilities

Clinical Trial Management

  • Support operational execution of global clinical studies.

  • Assist Global Trial Lead (GTL) in study planning and execution.

  • Manage study timelines, plans, and operational deliverables.

  • Support study startup, maintenance, and closeout activities.

  • Ensure study documentation is accurate and complete.


eTMF & Documentation Management

  • Maintain Trial Master File (eTMF) quality and completeness.

  • Manage study-level documentation.

  • Support study archival and closure activities.

  • Track protocol milestones and study progress.


Clinical Trial Systems Management

  • Maintain information in:

    • CTMS (Clinical Trial Management Systems)

    • eTMF Systems

    • Study SharePoint Sites

    • Global Vendor Site Lists

  • Manage country-level planning and study milestones.


Vendor Management

  • Support vendor oversight activities.

  • Track vendor performance and deliverables.

  • Review vendor invoices.

  • Support approval processes.

  • Manage Statements of Work (SOW) changes.

  • Support budget accrual activities.


Financial & Budget Management

  • Track study budgets.

  • Process vendor and site payments.

  • Monitor study accruals.

  • Assist with financial forecasting.


Regulatory & Compliance Support

  • Support:

    • Clinical Trial Applications (CTA)

    • Ministry of Health submissions

    • IRB/IEC approvals

    • Regulatory notifications

  • Ensure compliance with:

    • ICH-GCP Guidelines

    • Regulatory Authorities

    • Internal SOPs


Risk Management

  • Identify study risks proactively.

  • Develop mitigation plans.

  • Escalate critical issues appropriately.

  • Monitor study performance metrics.


Meeting & Communication Management

  • Organize study team meetings.

  • Prepare agendas.

  • Capture meeting minutes.

  • Present assigned study topics.

  • Communicate effectively with global stakeholders.


Study Closure Activities

  • Lead study archival activities.

  • Ensure all study documentation is complete.

  • Support Clinical Study Report (CSR) appendices.

  • Complete closeout deliverables.


Required Qualifications

Education

  • Bachelor's Degree (BA/BS) in Life Sciences, Pharmacy, Biotechnology, Clinical Research, or related field.

  • Master's Degree preferred.


Experience

  • 2–4 years of Clinical Research experience.

  • Experience in:

    • Clinical Trial Operations

    • Clinical Project Coordination

    • Clinical Study Management

    • CRO or Pharmaceutical Industry

  • Global clinical trial experience preferred.


Technical Skills

Clinical Systems

  • CTMS (Clinical Trial Management Systems)

  • eTMF Systems

  • SharePoint

  • Microsoft Office Suite

Clinical Research Knowledge

  • ICH-GCP Guidelines

  • Drug Development Process

  • Clinical Trial Regulations

  • Site Management

  • Vendor Management

Project Management

  • Study Planning

  • Timeline Management

  • Risk Management

  • Budget Tracking


Behavioral Competencies

  • Strong organizational skills

  • Attention to detail

  • Effective communication skills

  • Stakeholder management

  • Team collaboration

  • Problem-solving ability

  • Adaptability and flexibility

  • Leadership potential

  • Mentoring and coaching mindset


Work Environment

Travel Requirement

  • Less than 5%

Work Model

Depending on business requirements:

  • Site Essential (100% onsite)

  • Site-by-Design (Hybrid)

  • Remote-by-Design

  • Field-Based


Career Progression

Potential future roles include:

  • Senior Global Trial Associate

  • Clinical Trial Manager (CTM)

  • Clinical Operations Manager

  • Clinical Project Manager

  • Global Trial Lead (GTL)

  • Associate Director, Clinical Operations