Lead Clinical Site Manager – Study Start Up, In Vitro Diagnostic Regulation

Responsibilities

• Lead end-to-end study start-up activities
• Manage Ethics Committee (EC) and Competent Authority (CA) submissions
• Provide robust CRO oversight
• Act as the primary contact and clinical trial expert
• Develop critical study documentation

Requirements

• A degree in a scientific discipline or related field
• Direct experience in Clinical Operations
• Demonstrated experience in CRO oversight
• Strong understanding of In Vitro Diagnostic Regulation (IVDR)
• Exceptional verbal and written communication skills (English)

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