Description
Drive global clinical trials from first site activation to final patient visit,own the strategy, accelerate delivery, and shape the future of clinical research worldwide.
We are seeking a Global Study Manager responsible for the end-to-end planning, execution, and delivery of clinical trial site management activities across global studies. This role ensures successful site selection, activation, monitoring oversight, and closeout,while balancing speed, quality, and cost. You will serve as the primary point of contact for clients, lead cross-functional teams, and ensure compliance with ICH-GCP, regulatory requirements, and study protocols.
Key Responsibilities:
- Global Study & Site Leadership
- Lead site management strategy from study award through close-out
- Oversee site identification, selection, activation, and recruitment performance
- Ensure clinical monitoring processes meet study needs and timelines
- Partner with CRAs to optimize enrollment, data quality, and compliance
- Project & Stakeholder Management
- Serve as primary client contact and own key customer relationships
- Lead cross-functional teams across regions and cultures
- Facilitate internal and external meetings, including executive presentations
- Drive collaboration across stakeholders, vendors, and functional leads
- Operational Excellence & Risk Management
- Develop and manage integrated study plans and risk mitigation strategies
- Proactively identify risks and implement corrective/preventative actions
- Monitor study timelines, enrollment trends, and data quality metrics
- Ensure compliance with GCP, SOPs, protocols, and regulatory standards
- Financial & Contract Management
- Manage study financials, including forecasting and revenue acceleration
- Identify and manage out-of-scope work and change orders
- Oversee Billing Unit Reviews (BURs) and expense approvals
- Track performance against budget and Estimate at Completion (EAC)
- Quality & Compliance
- Maintain TMF health and ensure timely document submission
- Develop quality monitoring plans and compliance metrics
- Ensure adherence to study tools, training materials, and processes
- Team Leadership & Development
- Lead and mentor cross-functional project teams
- Support CRA and team training on therapeutic areas and study-specific needs
- Foster collaboration, knowledge sharing, and continuous improvement
Qualifications:
- Required
- Bachelor’s degree in life sciences or related field
- 5+ years of clinical research/monitoring experience, including 2 years in a clinical study management role
- Strong knowledge of ICH-GCP, FDA regulations, and clinical trial processes
- Experience managing global clinical trials and multi-regional teams
- Demonstrated experience in project financial management
- Core Competencies
- Exceptional communication and stakeholder management skills
- Strong problem-solving and risk mitigation capabilities
- Ability to influence without authority in matrix organizations
- High attention to detail and quality-driven mindset
- Proficiency in Microsoft Office and clinical systems (e.g., CTMS, EDC)
Why Join Us:
- Work on cutting-edge global trials across therapeutic areas
- Collaborate with top talent in a dynamic, global environment
- Make a direct impact on patient outcomes worldwide