Gestionnaire des études cliniques internationales
Core
Plan, lead, and supervise clinical studies from start to finish, ensuring efficiency, regulatory compliance, and high-quality data generation for innovative antibody-based medicines.
Role type
Senior Clinical Study Manager (International)
Builds
Clinical studies for antibody-based drug candidates in endocrinology, women's health, immunology, and oncology
Domain
Biotechnology / Clinical Research
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical study management, regulatory compliance (GCP), project planning and execution, risk management, data integrity oversight, budget and timeline management, stakeholder collaboration
Preferred skills
Clinical research associate experience, center-based research experience, ACRP or SOCRA certification
Technologies
Clinical trial management systems (CTMS), electronic data capture (EDC) systems
Responsibilities
Oversee global clinical study strategy including planning, execution, monitoring, and closure; Ensure studies adhere to approved protocols, GCP, and applicable regulations; Act as primary contact for International Project Directors of contracted research organizations; Collaborate with clinical project managers to translate global recruitment goals into country-specific execution plans; Draft and review study plans, protocols, and related documents while supervising site selection and feasibility assessments; Manage project schedules, milestones, and budgets; Identify study risks and develop mitigation strategies; Supervise data collection, analysis, and presentation ensuring data integrity and privacy compliance; Ensure participant safety and well-being through adverse event reporting and safety response protocols
