Alexion is seeking a Country Study Manager (CSM) to oversee clinical trial operations, ensuring compliance with regulatory standards and facilitating study deliverables. The role involves collaboration with various teams and stakeholders to achieve successful site activation, monitoring, and recruitment for clinical studies
Job Summary
The Country Study Manager is responsible for the quality and timeliness of study deliverables, including site identification, feasibility, start-up, recruitment, data deliverables, and filing of complete study documentation for assigned study(ies).
Key responsibilities include proactive reporting of study-specific issues, meeting recruitment targets, CDA delivery and negotiation, ICF customization, negotiation of site study contracts and budgets, and review of local regulatory documentation.
The role requires proven experience in clinical trial processes, strong knowledge of ICH-GCP, effective communication with site staff, and comprehensive regulatory knowledge, with a Bachelor's Degree or equivalent in a related discipline.
Matching Summary
Match Score: 85
Alexion is seeking a Country Study Manager (CSM) to oversee clinical trial operations, ensuring compliance with regulatory standards and facilitating study deliverables. The role involves collaboration with various teams and stakeholders to achieve successful site activation, monitoring, and recruitment for clinical studies.