Experience

CROMSOURCE - A ClinChoice Company

• Italy
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Clinical Research Director

  • Nov 2017 - Present



QuintilesIMS

• Project Manager

  • Oct 2012 - Nov 2017



Cromsource

• Clinical research leader

  • Jan 2009 - Oct 2012

  - Supervise the assigned multinational/multicenter projects - Collaborate in the development of study budget and supervise the respect of that during the whole study - Negotiate with third parties vendors the costs proposals for the assigned projects. - Management of project in different therapeutic areas (e.g cardiovascular, oncology, gastrointestinal, respiratory, virology) - Supervise the team work at site level through co-monitoring visits. - Support the preparation of bid defense meetings - Assist in drafting feasibility studies - Manage and coordinate the projects assigned to the project coordinators to maintains the planning of activities - Acts as tutor for junior project coordinator - Trainer in Monitors and Investigators meetings - Assist the medical leaders in preparing protocol, CRF and Clinical report - Primary project contact with Sponsor to facilitate the communications Show less



Crom srl

• Clinica research coordinator

  • Jan 2005 - Dec 2008

  - Manage and coordinate national and international clinical trials (both in the EU and Third Countries) . - Prepare the country specific agreements, confidentiality agreements, clinical trial applications and other applicable operations documents - Monitor study conduct and progress, proactively identifying and resolving issues which may impact the delivery of the study or to the necessary quality - Provide input to data management documents (e.g. Case Report Form, Data Management Plan) - Contribute to the planning and conduct of internal and external meetings (e.g. investigator/monitors meetings, Independent Safety Monitoring Committee meetings, study team meeting) - Key point of contact between the clinical operations and Clinical trial supplies vendors - Manage the third parties vendors (as DM & Statistics, central drug depots, central laboratories, couriers) - Coordinate & consolidate the supply delivery to the sites in conjunction with the different clinical teams Show less



GSK

• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Stage in direzione medica

  • Oct 2004 - Dec 2004

  CSR assistance CSR assistance