Regulatory Affairs Manager and Clinical Study Manager at San Raffaele Hospital, Milano (2015-07 – Present)
- Gene Therapy Regulatory Affairs Manager and Clinical Study Manager
- Regulatory Affairs Manager and Clinical Study Manager in Phase 1, Phase 1/2, Phase 3 Clinical Trials, Study of Collection of Biological Material, Observational Study, Register, Compassionate use, Hospital exemption and basic research trials on biological human material/biobank
- Contact for communications with the Technical Secretariat of the Ethics Committee and Competent Authority
- Contact person for communications with the Independent Ethical Committees and the local competent authorities for multicentric or monocentric Non-profit and Profit Studies
- Project team coordinator contributing to the clinical trial
- Responsible for managing the essential document required by the rules in force and applicable
- Management and organizational aspects related to the feasibility of the clinical trial
- Discussion with PI and medical Staff
- Organisation of procedures for initiating the study
- Organisation of quality control procedures
- Management of Sponsor or Promoter relations with San Raffaele Hospital Coordination and participation of Site Initiation Visits
- Monitoring, Audits, Inspection Visits
- Management of closure of ISF/ TMF
- Management of communication with regulatory Authorities
- Support for periodic reports (DSUR and Annual Safety Report), Reference for related external vendors and related contracts
- ISS Data Base Management
Regulatory Affairs Manager and Clinical Trials Coordinator at San Raffaele Hospital, Milano (2014-01 – 2015-06)
- Coordination of the different clinical research projects of the same clinical unit
- Coordination of the different professional roles of a clinical trial Respect of deadlines
- Meeting with the Principal Investigator Staff meetings
- Meetings with the Sponsor
- Assessment of the workload of each professional role and redeployment responsibility for regulatory submission of clinical protocol
- Responsibility for communication between Sponsor, Research Centre and Regulatory Authorities
- Contact person for communications with the Independent Ethical Committees and the local competent authorities for multicentric or monocentric Non-profit and Profit Studies
- Project team coordinator contributing to the clinical trial
- Responsible for managing the essential document required by the rules in force and applicable
- Management and organizational aspects related to the feasibility of the clinical trial
- Discussion with PI and medical Staff
- Organisation of procedures for initiating the study
- Organisation of quality control procedures
- Management of Sponsor or Promoter relations with San Raffaele Hospital Coordination and participation of Site Initiation Visits
- Monitoring, Audits, Inspection Visits
- Management of closure of ISF/ TMF
- Management of communication with regulatory Authorities
- Support for periodic reports (DSUR and Annual Safety Report), Reference for related external vendors and related contracts
- ISS Data Base Management
Clinical Research Assistant at San Raffaele Hospital, Milano (2012-01 – 2014-12)
- Evaluation of Clinical Protocols before the Ethics Committee
- Verification of the bureaucratic completeness of the documentation
- Verification of the Scientific integrity of the documentation
- Interview with the Principal Investigator
- Resolution of the scientific and bureaucratic criticalities of the documentation before the presentation of the protocol in the Ethics Committee
Senior Research Laboratory Technician at San Raffaele Hospital, Milano (1994-01 – 2012-12)
Neuroimmunology Unit. Basic laboratory research and technical support.
