The role of the Clinical Operations Manager/Start Up Lead is responsable for performance and compliance for assigned protocols in Italy with ICH/GCP and country regulations, policies and procedures, quality standards and adverse event reporting requirements internally and externally. […]
Interact with IRB/IEC and Regulatory Authority Supports country deliverables, timelines and results to meet country commitments Responsible for quality and compliance Contribute to the development of local SOPs Coordinate s and liaise s with CRM, CTC, CRA to ensure country deliverables are obtained Collaborate...