Global Trial Lead
Bristol Myers Squibb
14 hours ago
Remote friendly (Madison, NJ)
United States
Clinical Research and Development
Position Summary
The Global Trial Lead (GTL) provides strategic and operational oversight for global clinical trials, ensuring execution with excellence—on time, within budget, and in compliance with regulatory standards and internal policies.
Responsibilities
- Lead collaboration with internal teams and CRO/vendor partners to deliver trials meeting timelines, budgets, and quality benchmarks.
- Provide strategic input on feasibility; oversee operational activities.
- Proactively identify and manage risks; balance cost, deliverables, and quality trade-offs.
- Manage CRO/Vendor Partner scope of work (SOW) aligned to contracts, budget targets, and quality standards.
- Participate in vendor selection/evaluation; review/approve/reconcile vendor invoices, accruals, and scope amendments.
- Use performance metrics/quality indicators to monitor and optimize execution.
- Maintain accurate study data in systems such as Veeva (CTMS/eTMF).
- Develop/enforce trial-specific standards and global cross-functional best practices; establish study-level tools (action logs, trackers, issue registers, risk mitigation plans).
- Provide therapeutic/operational guidance on protocols and execution strategies; monitor clinical operations trends and advise responses.
- Drive upfront planning of timelines/budgets; manage vendor logistics; resolve budget/timeline issues; lead quarterly budget reviews and forecasting support.
- Provide lifecycle leadership for assigned trials from start-up through close-out.
Qualifications
- BA/BS (or equivalent) in relevant discipline.
- Minimum 4 years in clinical operations and project management in pharma/healthcare (including multinational experience).
- Experience leading global clinical trials; strong project management/organizational, presentation, and communication skills.
- Experience leading global, multi-functional teams in a matrixed environment.
- Experience managing CROs (preferred).
Skills/Competencies
- Global trial & project management; operational and budget oversight.
- Risk and quality management (GCP/GXP compliance; audit readiness).
- Stakeholder and vendor engagement; clinical & regulatory expertise.
- Systems/data management using CTMS and clinical systems.
Management competencies: leadership & collaboration, critical thinking/decision-making, accountability/results focus, adaptability/resilience, communication/relationship building.
Travel requirement: up to 25%.
Compensation (Madison/Giralda, NJ and Princeton, NJ)
- $135,470–$164,161.
Benefits (high level)
- Health coverage (medical, pharmacy, dental, vision); wellbeing support; 401(k) and insurance/disability benefits; paid time off (varies by location/role).
The Global Trial Lead (GTL) provides strategic and operational oversight for global clinical trials, ensuring execution with excellence—on time, within budget, and in compliance with regulatory standards and internal policies.
Responsibilities
- Lead collaboration with internal teams and CRO/vendor partners to deliver trials meeting timelines, budgets, and quality benchmarks.
- Provide strategic input on feasibility; oversee operational activities.
- Proactively identify and manage risks; balance cost, deliverables, and quality trade-offs.
- Manage CRO/Vendor Partner scope of work (SOW) aligned to contracts, budget targets, and quality standards.
- Participate in vendor selection/evaluation; review/approve/reconcile vendor invoices, accruals, and scope amendments.
- Use performance metrics/quality indicators to monitor and optimize execution.
- Maintain accurate study data in systems such as Veeva (CTMS/eTMF).
- Develop/enforce trial-specific standards and global cross-functional best practices; establish study-level tools (action logs, trackers, issue registers, risk mitigation plans).
- Provide therapeutic/operational guidance on protocols and execution strategies; monitor clinical operations trends and advise responses.
- Drive upfront planning of timelines/budgets; manage vendor logistics; resolve budget/timeline issues; lead quarterly budget reviews and forecasting support.
- Provide lifecycle leadership for assigned trials from start-up through close-out.
Qualifications
- BA/BS (or equivalent) in relevant discipline.
- Minimum 4 years in clinical operations and project management in pharma/healthcare (including multinational experience).
- Experience leading global clinical trials; strong project management/organizational, presentation, and communication skills.
- Experience leading global, multi-functional teams in a matrixed environment.
- Experience managing CROs (preferred).
Skills/Competencies
- Global trial & project management; operational and budget oversight.
- Risk and quality management (GCP/GXP compliance; audit readiness).
- Stakeholder and vendor engagement; clinical & regulatory expertise.
- Systems/data management using CTMS and clinical systems.
Management competencies: leadership & collaboration, critical thinking/decision-making, accountability/results focus, adaptability/resilience, communication/relationship building.
Travel requirement: up to 25%.
Compensation (Madison/Giralda, NJ and Princeton, NJ)
- $135,470–$164,161.
Benefits (high level)
- Health coverage (medical, pharmacy, dental, vision); wellbeing support; 401(k) and insurance/disability benefits; paid time off (varies by location/role).