Senior Global Trial Lead
Company: Bristol Myers Squibb
Location: Hyderabad
Department: Global Clinical Operations / Global Trial Management
Job Type: Full-Time
Role Summary
The Senior Global Trial Lead (SGTL) is responsible for the strategic leadership, planning, execution, and oversight of global clinical trials across all study phases. The role ensures studies are delivered on time, within budget, and in compliance with regulatory, quality, and operational requirements.
The position serves as the primary operational leader for assigned studies, managing cross-functional teams, CROs, vendors, budgets, timelines, risks, and overall study execution from start-up through close-out.
Key Responsibilities
Clinical Trial Leadership
Lead global clinical trials from study start-up through study closure.
Ensure delivery of trials according to timeline, budget, quality, and compliance requirements.
Coordinate activities across global cross-functional study teams.
Drive operational excellence and continuous improvement throughout study execution.
Project Management
Collaborate with internal teams and external vendors to ensure successful trial delivery.
Establish and manage:
Project timelines
Action logs
Decision trackers
Risk registers
Issue management plans
Monitor study progress and resolve operational challenges.
Ensure effective communication and alignment across stakeholders.
Vendor & CRO Management
Manage Contract Research Organizations (CROs) and vendor partnerships.
Develop and oversee Scope of Work (SOW) agreements.
Participate in vendor selection, evaluation, and performance reviews.
Review and approve:
Vendor invoices
Budget accruals
Change orders
Scope amendments
Ensure vendor compliance with quality and contractual requirements.
Risk Management & Operational Strategy
Identify and proactively manage study risks.
Balance quality, timelines, and budget considerations.
Develop mitigation and contingency plans.
Monitor operational trends and recommend strategic improvements.
Study Planning & Feasibility
Provide operational and therapeutic-area guidance during study planning.
Contribute to protocol feasibility assessments.
Support development of execution strategies and operational plans.
Advise study teams on best practices and risk mitigation approaches.
Budget & Resource Management
Lead study budget planning and forecasting activities.
Conduct quarterly financial reviews.
Track budget utilization and identify variances.
Partner with finance teams for forecasting and financial planning.
Escalate resource and budget concerns as required.
Study Oversight & Governance
Lead cross-functional Global Study Teams.
Monitor study performance using operational metrics and KPIs.
Ensure compliance with:
ICH-GCP Guidelines
Regulatory Requirements
Internal SOPs
Maintain accurate records in:
Veeva CTMS
eTMF
Other clinical trial management systems
Stakeholder Management
Build strong partnerships with:
Clinical Research Teams
Medical Affairs
Regulatory Affairs
Data Management
Biostatistics
Regional Affiliates
CROs and Vendors
Facilitate knowledge sharing and cross-functional collaboration.
Serve as a key operational contact for study-related activities.
Mentorship & Leadership
Mentor Global Development Operations (GDO) team members.
Support development of junior trial management professionals.
Promote adoption of global best practices and operational standards.
Contribute to organizational capability building.
Preferred Qualifications
Education
Bachelor's Degree in Life Sciences, Pharmacy, Medicine, Nursing, or related discipline.
Advanced degree preferred.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
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