Head of Operation Department
Since September 2013
•Defines project teams, allocation of responsibilities, personal objectives and performance evaluation of Operation staff. •Coordinates and takes part to training of staff with a lower level of working experience and su-pervises their work to assure the adherence to ICH/GCP/EU and Italian Reg. •Interaction between Sponsors/CROs and Investigators during clinical studies management (in details, during “Site Selection Visit”, Site Initiation Visit, Monitoring Visits and “Site Closure Visit”). •Cooperates with Scientific Director to activate and develop relationships with new Spon-sors/CROs and to check the feasibilities of new Study Protocols. •Collaborates with Scientific Director to manage the CRC facilities and the relationships with Ve-rona Teaching Hospital and local EC which supervises clinical trials. •Supervises and coordinates of clinical trials at “Centro Ricerche Cliniche di Verona” and at the Hospital Departments, if required, in order to achieve objects within deadlines agreed and ac-cording to the Contract signed •Collaborates with CromSource “Supportive Functions” in order to monitor and periodically monitor processes related to supportive functional area and takes part into intercompany processes/Groups as “Good Management Practice team” •Cooperation with Legal Affairs Department to finalize Agreements and with Finance Department to assure the regular payments for clinical trials activities. •Collaborates with QS Manager in order to guarantee the coherence of system and conformity to laws in force and procedures. •Responsible to inform the staff about incoming Laws, Decrees, Regulations, Guidelines in Clinical Research •Responsible to deliver courses to the Internal staff and outside • Check of study documentation to be submitted for Regulatory Authorities evaluation according to the applicable Laws •Management of Investigational Medicinal Products (IMP), of its delivery, storage and accounta-bility according to GCP and GMP.
Senior Project Manager/Pharmacist/Coordinator of Sponsored Clinical Trials Unit
Since March 2011
As Project Manager and Pharmacist she has more than 13 years experience in managing mainly Phase 1 and Phase 2, but also Phase 3 and 4 clinical trials Healthy Volunteers, Oncology, Pediatric Oncohematology, Dental Pain, Neurological (ALS, MS), Rheumatology, Cystic Fibrosis, Pancreatic Insufficiency, Respiratory. As Co-ordinator for the “sponsored studies support unit” she managed all studies submitted to AOUI Verona EC starting on 2011, included observational and medical devices clinical trials.
January 2006 --- January 2011
Project Manager/ Pharmacist for Centro Ricerche Cliniche di Verona (CRC) CRC Quality System Manager ( UNI EN ISO 9001:2008) CRC SOP Administrator
March 2002 --- December 2005
During the first period, until November 2003 she worked as Study Co-ordinator in Clinical Trial Supply-Packaging (CTS-P) Unit under Pharmaceutical Development Department. From November 2003 to December 2005 she worked as Pharmacist responsible/Study Co-ordinator in Clinical Pharmacology and Discovery Medicine Unit and in 2005 she attended a secondment as Study Team Leader in Clinical Science &Study Operations (CSSO) Psychiatry Verona Group.
PhD in Translational Biomedicine from Università degli Studi di Verona in 2011
Chemistry and Pharmaceutical Technologies in Pharmacy from Università degli Studi di Padova in 2001
Maturità classica in Adult High School/Secondary Diploma Program from Liceo Ginnasio "Tiziano" in 1995
Training and Certification
Certificate to practice the profession of Pharmacist Certification