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Current Experience

  • Clinical Quality Assurance Auditor (GCP),
    Since September 2015
    - Perform clinical audits in order to ensure compliance with study protocols, GCP, SOPs and regulations. Identify any general issues, track deviations, propose related CAPAs and ensure follow up as necessary. - Check study protocol and its relevant amendments for compliance with GCP and other applicable guidelines. - Review company SOPs and controlled documents and working instructions. - Write and circulate audit reports and other documentation to the involved function/s and ensure findings follow up as appropriate. - Develop and execute a comprehensive annual audit plan for clinical trials - Organize and deliver specific training sessions dealing with GCP and clinical quality to clinical staff and investigators.

Past Experience

  • Affiliate Process & Training Advisor
    October 2014 --- August 2015
    - Provide guidance on implementation of ICH GCP, SOPs and other controlled documents, regulatory and local law requirements and to conduct process and training oversight activities, applying risk based triggers for further activities/escalation. - Recommend and implement improvements to processes or tools to achieve quality standards and efficiencies. Recommend, write and maintain affiliate SOPs and other procedures. - Ensure the local training curriculum is aligned with the global Training Grid and local needs and that training is appropriately assigned to the specific job functions. - Develop and deliver new training modules based on identified training needs and prepare and deliver Orientation programs for new hires. - Ensure the affiliate is GCP inspection and audit ready, support affiliate staff in the identification and management of risks or issues affecting study conduct and the development of effective mitigation plans. - Provide audit/inspection and process and training related issues support to all affiliate staff, as needed, ensure Corrective Actions and Preventive Actions for affiliate level risks and issues are effectively implemented in order to mitigate impact in key areas. - Ensure best practices are shared

  • QA Product Assurance Expert
    August 2014 --- September 2014

  • QA GCP Document Management and Control
    September 2013 --- July 2014
    Collaborate with GCP Compliance Specialist to: - Write, review and update SOPs and related documents. - Plan, coordinate and conduct internal and external GCP training - Develop and execute a comprehensive annual audit plan for clinical trials - Plan, coordinate and conduct internal audits, clinical sites’ audits and contractors’ audits (departmental processes and documents) to assess compliance with US and EU regulation, ICP/GCP guidelines and Gentium Quality system - Appoint members of different company departments in order to evaluate/assess deviations/violations from GCP and Gentium Quality System and ensure that they are properly tracked, communicated, investigated and solved. Verify suitability and effective implementation of the agreed corrective actions

  • Data Manager
    June 2013 --- August 2013
    Drug accountability,specific clinical study eCRF upgrade, AE reports, communication management between PIs and CRAs.

  • Theoretical clinical monitor training according to the D.M. 15.11.2011
    April 2013 --- April 2013
    - Methodology and legislation of clinical trial - Good Clinical Practice (GCP) - Good Manufacturing Practice (GMP) in specific reference to drug in trial. - Pharmacovigilance - Quality systems and Quality Assurance - Clinical monitor’s tasks in reference to paragraph 5.18 of the attachment 1 of the D.M. 15.07.1997

  • Chemical analyst in Quality Control Laboratory
    February 2012 --- December 2012
    Organic chemistry applied to petrochemical laboratory quality control of industrial and engine oils. Use of IR spectrophotometer with cells and ATR plate, use of hydrometer, viscometer and colorimeter analysis of trace metals with X-rays and plasma ICP. Knowledge and evaluation of tests of foams and emulsions, COC flash point, viscosity CCS, rust and corrosion tests, tests of air release, cracle test. Knowledge of internal and external quality manuals (ISO 9000).

  • Pharmaceutical representative
    September 2011 --- January 2012

  • Internship at the Laboratory of Clinical Biochemistry and pathology
    June 2011 --- August 2011

  • Research Scholarship
    October 2010 --- February 2011
    research on mechanism of action of thyroid hormones lipid accumulation


LinkedIn Assessment :
Clinical monitoringClinical researchCell Culturemolecular biologyPharmaceutical IndustryClinical trialsoncologyGCPCROICH-GCPClinical DevelopmentCTMSSOPRegulatory affairsPharmacovigilanceRegulatory submissionsBiotechnologyPharmaceutical salesEDCGMPSOPIndustria FarmacSperimentazioni clinicheFarmacovigilanzaProgettazione di studi cliniciBiologia molecolareColtura cellulareBuona pratica clinicaMonitoraggio clinicoOncologRicerca clinicaNorme di buona fabbricazioneBiotecnolog


  • Attendance at the course “Theoretical clinical monitor training according to the D.M. 15.11.2011” in Theoretical clinical monitor training according to the D.M. 15.11.2011 from Yghea clinical research organisation, a division of Bioikòs Ambiente s.r.l., Bologna in 2013
  • Master's degree in Medical Biological Sciences from Università degli Studi di Genova / University of Genoa in 2010
  • Overcoming the professional test to became a licenced biologist in from Università degli Studi di Genova / University of Genoa in 2010
  • Bachelor's degree in Biological Sciences in Biological Sciences from Università degli Studi di Genova / University of Genoa in 2008

Training and Certification

  • First Certificate Certification
  • PET Certificate Certification

Area / Region

Rome, Metropolitan City of Rome, Italy


Driving License
  • No