Global Study Manager
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OverviewIn 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.
ResponsabilidadesLead 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
Requisitos principalesUniversity 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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