Our client is currently looking to strengthen their Ethics and Regulatory department and are seeking an experienced Manager Study Start Up & Regulatory to be based near Milan.
A brief summary of duties you will be involved in:
• Assisting senior managers, managing work and teams within a specific or broad area of site start-up, such as site activation, regulatory, submissions, site contracts, or regulatory records. • Line Management • Ensuring fulfillment of customer requirements and compliance with related regulations. • Analyzing processes and developing strategies to increase efficiency. • Performing operational level planning, including efficient allocation of resources within the department. • Participating in business development presentations as a subject matter expert in Site Start-Up & Regulatory functions within the Company.
• Moderate experience in a clinical research organization (CRO) and related contract management or site start-up experience. • Experience managing staff preferred. • Thorough knowledge of applicable regulations, drug development, and clinical project management procedures.