Global Clinical Study Senior Manager
New
USFull-TimeManager
Salary143,300 - 193,300 USD per year
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Job Details
- Experience
- 5+ years
- Required Skills
- Project ManagementRisk ManagementStakeholder managementBudget management
Requirements
- Bachelor’s degree in a scientific or healthcare discipline
- 5+ years of experience in clinical trial project management within biotech, pharmaceutical, or CRO environments
- Proven experience leading global clinical studies and cross-functional clinical operations teams
- Strong understanding of clinical trial processes, including feasibility, site management, data flow, and regulatory submissions
- In-depth knowledge of ICH-GCP guidelines, clinical quality standards, and global regulatory requirements
- Experience managing clinical study budgets, forecasting, and resource planning
- Strong leadership skills with the ability to coordinate regional and global stakeholders effectively
- Excellent communication skills
- Strong analytical thinking, problem-solving, and risk management capabilities
Responsibilities
- Serve as the global single point of accountability for clinical study execution, including timelines, quality, enrollment, and budget performance
- Lead global clinical operations teams and coordinate regional study managers and external partners to ensure consistent execution
- Oversee study planning activities including start-up strategy, feasibility, site selection, enrollment acceleration, and activation timelines
- Ensure alignment across Clinical Operations, Medical, Regulatory, Biometrics, Supply Chain, and other key functions
- Manage study governance, ensuring timely updates, escalation of risks, and implementation of mitigation strategies
- Oversee data flow, query resolution, and trial master file maintenance to ensure accuracy and inspection readiness
- Collaborate with clinical supply teams, CRAs, and vendors to ensure proper study execution at site level
- Lead quality oversight, ensuring compliance with ICH-GCP, SOPs, and regulatory requirements across all regions
- Manage study budgets, forecasts, and resource allocation in partnership with finance and operational teams
- Support audits, inspections, and quality assurance activities, ensuring timely and effective resolution of findings
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