Start up Manager

Pharmiweb

Palermo, PA

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

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.

Key Responsibilities Include
• Execute and oversee clinical trial country submissions and approvals
• Develops local language materials including language Informed Consents and translations. 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... More Detail

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