Experteer Overview In this role you enable end-to-end delivery of clinical studies within Integral 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.Compensaciones / Beneficios- 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 managementResponsabilidades- 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 constraintsRequisitos principales-

📌 Global Study Manager - Single Sponsor Dedicated (Les)
🏢 Contract Research Organisation
📍 Les