Experience

CROMSOURCE - A ClinChoice Company

• Italy
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Project Manager

  • Oct 2020 - Present



ROTTAPHARM BIOTECH S.R.L.

• Italy
• Research Services
• 1 - 100 Employee

• Clinical Research Manager

  • Apr 2014 - May 2020

  Preparation of regulatory authority and ethics committee submissions for multi-centre studies; management of multi-centre studies; preparation and revision of operational manuals; Trial Master File (both paper and eTMF) management and revision; training for the training “on the job” to CRA; interaction with CROs, investigators and site staff. Preparation of regulatory authority and ethics committee submissions for multi-centre studies; management of multi-centre studies; preparation and revision of operational manuals; Trial Master File (both paper and eTMF) management and revision; training for the training “on the job” to CRA; interaction with CROs, investigators and site staff.



ROTTAPHARM S.P.A.

• Italy
• Pharmaceutical Manufacturing

• Junior Clinical Research Manager/CRA

  • Jan 2010 - Apr 2014

  Collaboration in preparation of regulatory authority and ethics committee submissions for single-centre and multi-centre studies with IMP and Nutraceuticals; management of Phase II studies in Gastroenterology; IMP management; trainer for IMP management to CRA (CRA Meeting); monitoring of Phase II studies in Gastroenterology, Oncology and Neurology; monitoring and co-monitoring of Phase I studies; Trial Mater File revision.

• Clinical Research Associate

  • Oct 2007 - Dec 2009

  Monitoring of phase I and phase II single-centre studies in Gastroenterology; co-monitoring of a multi-centre study in Rheumatology.



Innopharma Srl

• Italy
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Clinical Research Associate

  • Apr 2006 - Oct 2007

  Monitoring of different types of multi-centre studies (Epidemiologic study, Expanded Access Protocol study, Phase III studies) in Nephrology, Oncology, Gynaecology; preparation and attendance to “on site” audits. Monitoring of different types of multi-centre studies (Epidemiologic study, Expanded Access Protocol study, Phase III studies) in Nephrology, Oncology, Gynaecology; preparation and attendance to “on site” audits.