Over 25 years experience in Clinical Operations, from Medical Writing through CRA/CRM to Director Clinical Operations (pharma/biotech).
- Member of taskforce to harmonize and standardize processes/documents for Clinical Development across branches of large pharmaceutical company.
- Organized and supervised local and international Phase I-III trials, including Orphan Indication, mainly in (but not exclusive)
- Rheumatoid Arthritis
- Multiple Sclerosis
- lamellar ichthyosis
- Allergies (rhinitis, conjunctivitis)
- Set-up Clinical Operations Department in starting biotechs.
- Coordinated (GxP) Quality Management System and Document Management System set-up.
Associate Director Clinical OperationsNovember 2012 --- October 2013
Senior Manager Clinical OperationsJune 2008 --- September 2012
Director Clinical Operations EURApril 2002 --- March 2008
CRMJanuary 1982 --- January 2001
CRA/CRMJanuary 1982 --- January 1997
LinkedIn Assessment :
Certificate in Italian from Centre for Adult Education (evening classes) in 2010
Master in Translation, English & Spanish from HIVT (RUCA) in 1981
Area / Region