Emanuele Borroni

•Leading the site management and regional monitoring team on a project, providing oversight, training and mentoring as required •Liaising With Internal and External Customers to meet project specific goals •Coordinating submissions to Regulatory Authorities, IECs and other bodies •Interfaces with other project team members to ensure that study milestones are achieved •Managing time and project requirements based on study contract; identifies and documents out of scope activities

- Managing study sites to ensure adherence to the late phase study design - Implements and monitors post-marketing studies to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH guidelines - Coordinates and conducts telephone PSSV, SIV, and COV visits - Supporting Operational Team Lead/Lead SMA in management of clinical budget and evaluation of study processes

−Completing study start-up activities including the evaluation of potential sites, collection of regulatory documents and site agreement negotiations. −Providing site status updates to Project Manager. −Completing monitoring visits to ensure the integrity of clinical data and appropriate follow up procedures, including source document verification and SAE reporting