Global Study Manager
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In this role you enable end-to-end delivery of clinical studies within Global Study Management, ensuring time, cost and quality objectives from CSP development to CSR and archive. You collaborate with cross-functional teams and external partners to manage delegated study activities under GSD/GSAD supervision. You drive study readiness, supplier interactions, and risk mitigation while maintaining inspection-ready documentation. You will work on improving processes and supporting budget and project governance to deliver impactful clinical programs.
Responsabilidades- Lead preparation of delegated study documents (e.g., ICF, master Clinical Study Agreement) and study-specific procedures with internal and external stakeholders
- Coordinate with CROs and external vendors to ensure timely, quality-driven study delivery within budget
- Plan and conduct internal and external meetings (Investigators’/Monitors’ meetings)
- Ensure Investigational Product and study materials supply through Clinical Supply Chain or providers
- Identify risks and issues; develop mitigation/action plans
- Verify completeness and quality of study documents in Trial Master File
- Support budget management and invoice reconciliation with GSD/GSAD
- Adhere to ICH/GCP and global processes to maintain inspection readiness
- Assist GSD/GSAD with overall project management and SLA-based oversight of outsourced studies
- Lead process improvement initiatives as assigned by management
- University degree or equivalent in a relevant field
- Minimum of 3 years' pharmaceutical industry or academic experience in clinical research
- Knowledge of clinical development processes across phases and therapy areas
- Excellent knowledge of ICH/GCP guidelines
- Strong communication and relationship-building skills, including external vendor management
- Good project management skills
- Ability to collaborate cross-functionally and work independently
- Demonstrated leadership skills
- Proficient computer skills and daily tools
- English language: excellent verbal and written communication
- Please note visa sponsorship not available and location-based eligibility constraints
- communication
- relationship building
- collaboration
- external service provider management
- budget management
- trial master file quality control
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