Roberto Restelli

Background

About Roberto Restelli

Clinical Research Expert with an extensive experience in Local and Head Quarter Offices of Pharmaceutical Companies and Contract Research Organization. As Site Partnership Manager, I proactively plan and execute country-level sites strategy in collaboration with the key CSU stakeholders and Medical Affairs, based on study priorities, disease assets and country needs. I build relationships, enhance level of collaboration, and harness input and insights from Investigational sites to drive site performance such as increasing the number of patients/site, accelerating study start up and reducing overall development milestones through faster patient recruitment. I act as dedicated point of contact across and in between studies to identify with the right stakeholders any obstacles that can limit the site performance. As Clinical Project Leader role in the Clinical Study Unit in Sanofi I coordinated the clinical activities on international trials ensuring that all aspects of study management in the assigned countries are conducted within quality standards and in agreement with ICH/GCP and local regulations. I coordinated external CRO staff for outsourced activities and I manage and oversight trial budget. As Clinical Trial Manager at Alfasigma International Medical Affairs division I supervised local interventional and non-interventional clinical projects run worldwide by affiliates. I managed international company sponsored projects outsourced to selected CROs. I was also the main reference for Investigator Initiated Study supported by the company. As Sr. Regulatory Coordinator I worked in an international CRO. In close cooperation with the Regulatory Manager I led the Regulatory international teams in large scale studies from phase I to I was responsible for selection and coaching of Start-up and Regulatory personnel assigned to the project team. As Clinical Study Coordinator at IPSEN Medical Affairs department, I contributed to the Clinical Research Unit development. I was responsible for all aspects of the project from both operational and line management perspectives, I coordinated overall clinical trials from start up through close out to ensure compliance with ICH-GCP and local regulations and I provided oversight for project training and personal development plans for team members. As Scientific Advisor at IPSEN, I liaised with Key Opinions Leaders, Product Managers, Medical Managers to provide medical support to promotion strategies of products and to organize meetings and post-marketing activities.