Associate Director, Global Trial Lead
Company: Bristol Myers Squibb
Location: Hyderabad
Department: Global Clinical Operations / Global Trial Management
Job Type: Full-Time
Role Summary
The Associate Director, Global Trial Lead (AD-GTL) is a senior clinical operations leader responsible for the strategic planning, execution, oversight, and delivery of global clinical trials and clinical development programs. The role provides leadership across multiple studies, ensuring high-quality execution, regulatory compliance, budget management, risk mitigation, and operational excellence throughout the clinical trial lifecycle.
The position serves as a key partner to cross-functional teams, CROs, vendors, and senior stakeholders while driving portfolio-level strategies and mentoring trial management professionals.
Key Responsibilities
Global Clinical Trial Leadership
Lead the planning, execution, and oversight of global clinical trials.
Ensure studies are delivered on time, within budget, and according to quality standards.
Provide operational leadership from study start-up through study close-out.
Drive consistency across studies through implementation of global best practices and standards.
Project Management
Collaborate with internal teams and external vendors to achieve study objectives.
Establish and maintain:
Project timelines
Risk registers
Decision trackers
Action logs
Issue management plans
Monitor project performance and ensure timely resolution of operational challenges.
Support strategic decision-making throughout study execution.
Vendor & CRO Oversight
Manage CROs and external vendor relationships.
Develop and oversee Scope of Work (SOW) agreements.
Participate in vendor selection, qualification, and performance assessments.
Review and approve:
Vendor invoices
Budget accruals
Contract amendments
Scope changes
Ensure vendor compliance with contractual and quality expectations.
Strategic Study Guidance
Provide therapeutic-area and operational expertise for protocol development and study execution.
Advise teams on clinical operations trends, risks, and mitigation strategies.
Support operational excellence initiatives across programs and studies.
Provide strategic consultation to study teams and leadership.
Budget & Resource Management
Lead study and program budget planning activities.
Partner with cross-functional teams to forecast timelines and resource requirements.
Conduct quarterly budget reviews and financial forecasting.
Monitor study expenditures and address budget variances proactively.
Escalate resource constraints and operational risks when necessary.
Program & Portfolio Oversight
Oversee multiple clinical trials and development programs simultaneously.
Ensure alignment of study execution with broader portfolio and franchise objectives.
Monitor operational metrics and performance indicators.
Identify opportunities for process optimization and efficiency improvements.
Support strategic planning across programs and therapeutic areas.
Cross-Functional Leadership
Lead Global Study Teams and coordinate activities across:
Clinical Operations
Medical Affairs
Regulatory Affairs
Data Management
Biostatistics
Drug Supply
Quality Assurance
Facilitate effective communication and knowledge sharing among stakeholders.
Build strong partnerships with internal departments and external collaborators.
Mentorship & Talent Development
Mentor Global Development Operations (GDO) Study Team members.
Support professional development within the department and broader organization.
Share best practices and contribute to capability-building initiatives.
Promote a culture of operational excellence and continuous improvement.
Technical Competencies
Global Trial & Project Management
Advanced expertise in planning, managing, and executing global clinical trials.
Strong understanding of study lifecycle management and operational strategy.
Ability to manage complex, multinational clinical research programs.
Clinical Operations Leadership
Extensive experience leading cross-functional study teams.
Strong decision-making and problem-solving capabilities.
Expertise in risk identification, mitigation, and escalation management.
Regulatory & Compliance Knowledge
Strong knowledge of:
ICH-GCP Guidelines
Global Regulatory Requirements
Clinical Trial Compliance Standards
Experience maintaining inspection-ready study documentation.
Clinical Systems Expertise
Experience with:
Veeva CTMS
eTMF
Clinical Trial Management Systems
Study Performance Dashboards
Preferred Qualifications
Education
Bachelor's Degree in Life Sciences, Pharmacy, Nursing, Medicine, or related field.
Advanced degree preferred.
Experience
Significant experience in Global Clinical Trial Management.
Experience leading multiple global studies and development programs.
Strong background in vendor and CRO management.
Experience managing study budgets and forecasting activities.
Proven leadership experience in clinical operations.
Uttar Pradesh :
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