Simone Morandi

Sma i @ICON plc

Milan, IT

Completion of essential document collection and review throughout the studylifecycle. Organization and maintainance of site clinical trial master file (TMF)documents- Setting up and maintainance of site-related data according to procedures andguidelines- Ensurance of timely and complete data entry by site- Performing risk assessment and management responsibilities throughout theproject including site process evaluation, addressing follow up items and issueescalation- Performing all tasks in accordance with applicable guidelines,(e.g, ICH-GCP),company and sponsor SOPs, project plan, study-specific processes, localregulatory requirements- Setting up and maintainance of study documentation in applicable systems,e.g, clinical trial management system (CTMS), TMF system, applicablesite/sponsor systems according to project protocol, applicable SOPs andproject plans- Performing routine essential document collection, review, negotiation toensure successful site maintenance and closeout tasks- Ensuring that activities, documents and all other clinical data are accuratelytracked and documented for the project lifecycle- Ensuring site management communications as outlined in the study plans- Graduated Bridge CRA since 2024