Senior Global Clinical Study Manager
New
J
JobgetherBiotechnology, Pharmaceutical
Based in United StatesFull-TimeSenior
Salary$136,400 – $181,400 USD
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Job Details
- Experience
- 7+ years of progressive experience in clinical research, clinical operations, or global study management
- Required Skills
- Project ManagementBudget managementRisk Management
Requirements
- Bachelor’s degree in a scientific, healthcare, or related discipline required; advanced degree preferred.
- 7+ years of progressive experience in clinical research, clinical operations, or global study management within biotechnology, pharmaceutical, or CRO organizations.
- Proven experience independently leading global clinical studies from feasibility through completion.
- Strong project management expertise with demonstrated ability to manage timelines, budgets, resources, and cross-functional teams.
- Advanced knowledge of clinical operations processes, clinical trial methodologies, regulatory requirements, and ICH/GCP standards.
- Oncology clinical study experience preferred.
- Experience managing external vendors, clinical trial systems, and global study technologies.
- Strong understanding of risk management, quality oversight, inspection readiness, and regulatory compliance practices.
- Proficiency with MS Office, project planning applications, and clinical trial management systems.
- Willingness to travel as required by business needs.
Responsibilities
- Lead global cross-functional clinical study teams, ensuring effective decision-making, alignment on objectives, and timely resolution of study-related challenges.
- Manage external vendors and partners involved in study execution, ensuring performance, quality, and adherence to agreed deliverables.
- Develop and maintain comprehensive study plans, timelines, milestones, risk assessments, and operational strategies across global regions.
- Oversee clinical trial execution, including site selection, activation, enrollment support, monitoring activities, data cleaning, and study closeout.
- Ensure clinical studies remain compliant with protocols, SOPs, ICH/GCP guidelines, regulatory requirements, and internal quality standards.
- Drive risk-based quality management processes, identify potential issues, and implement mitigation and corrective action plans.
- Maintain inspection readiness by ensuring accurate documentation, Trial Master File quality, audit preparation, and regulatory compliance.
- Manage study budgets, resource planning, vendor payments, forecasting, and financial reporting to ensure delivery within approved parameters.
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