Alessandra Bergami

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.

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