Experience in Clinical multi-national Observational and Phase II- IV studies, Nutraceutical Products and Medical Devices.Main responsibilities as Project Manager:-When delegated by Sponsor, to draw up study documentation -If required by Sponsor, to apply for EndraCT code and to fill in all forms required for applications to Competent Authority and to Ethics Committee. -To organize Study meeting and training dedicated to Investigators and to CRAs and other study staff, unless… Show more Experience in Clinical multi-national Observational and Phase II- IV studies, Nutraceutical Products and Medical Devices.Main responsibilities as Project Manager:-When delegated by Sponsor, to draw up study documentation -If required by Sponsor, to apply for EndraCT code and to fill in all forms required for applications to Competent Authority and to Ethics Committee. -To organize Study meeting and training dedicated to Investigators and to CRAs and other study staff, unless organized directly by the Sponsor.-To manage of authorization procedures with the Ethical Committee and the Competent Authority, ensuring the compliance with regulatory requirements, keeping contacts and timely updating the Sponsor.-To check the various phases of clinical studies even through monthly study planning, highlighting the outlook for the results obtained and any consequences for the planned time and costs. -To manage the flow of study drugs to clinical sites, according to regulatory provisions and to Protocol requirements.-To coordinate the activities of CRAs involved in the study in according to the Monitoring Plan and to check the timeliness and the correctness of documentation collected during the same visits, such as CRF Pages, Monitoring Reports, and so on.-To perform co-monitoring with CRAs, to ensure the study is being conducted in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) and applicable regulatory requirements.-Sponsor liaison and management of communication between project team.-Report study progress/update to Sponsor.-Direct co-operation with the Data Management and Statistics Department.-To assist audits and inspections.Areas of experience:-Neurology, Psychiatry, Orthopedics, Immunology, Gastroenterology/Hepatology/Infectious Diseases, Respiratory, Oncology, Emergency Medicine, Rare Diseases. Show less

CRA for about 20 years on clinical studies (phases I, II, III and IV), observational, nutraceutical products, medical device conducted according to GCP.Main responsibility as CRA:-Perform site selection, initiation, monitoring and close-out visits in accordance with GCP and Sponsor SOPs-Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.-Evaluate the quality and integrity of study site practices related to the proper conduct of… Show more CRA for about 20 years on clinical studies (phases I, II, III and IV), observational, nutraceutical products, medical device conducted according to GCP.Main responsibility as CRA:-Perform site selection, initiation, monitoring and close-out visits in accordance with GCP and Sponsor SOPs-Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.-Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. -Escalate quality issues to Clinical Team Leader and/or line manager.-Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form completion and submission, data query generation and resolution.-Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation.Areas of experience:Cardiology, Gastroenterology, Haematology, Hepatic disease, Neurology, Oncology, Pneumology, Metabolic Disease, Psychiatry, Orthopedy, Rare Disease/Pediatrics, Immunology, Emergency Medicine, Neuro-Urology. Show less