BrightOwl Loader Loading

Experiences

Current Experience

  • Data Manager
    Since January 2014

Past Experience

  • Data Manager Consultant
    March 2012 --- December 2013
    Working within the R&D department of a Pharmaceutical company based in Switzerland, the role includes: - Planning, definition and evaluation of the data management activities and issues in clinical trials related to clinical study protocols, data validation plans, CRFs design, data cleaning, database structure, according to agreed upon timelines and quality expectations; - Managing external vendors on assigned studies; - Conducting the cross-functional Data Review and develop the Data Management study timeline, overseeing vendor DM activities, including timelines and quality of deliverables, and also reviewing listings and reports, ensuring study compliance with SOPs and regulations; - Supporting the creation of standardized, integrated data sets for pooled analysis, global data sharing, Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE) and electronic submissions to FDA. Assurance of CDISC compliance (SDTM and ADaM).

  • Lead Data Manager
    September 2011 --- February 2012
    Collaborate with sponsors and study team to develop the data collection specification from all data sources, manage in-stream data flow activities and deliver a quality database in accordance with the data management project plan. Lead and drive the data management team, represent the team vs the sponsor.

  • Data Manager - Programmer
    July 2008 --- September 2011
    Overall responsibility for handling 4-5 studies running concurrently. Planning, implementing and delivering the project in accordance with the contract agreed with the sponsor. Understanding & review of the project contract in order to ensure that any out of scope work is raised promptly and efficiently. Communicate with the project team as well as with investigative site personnel, and/or sponsor personnel. Keep the project team and other relevant contacts informed of project status in relation to both quality and timelines. Representing DM on the Trial Team. Contributing to the design of protocols. CRF designing and key documents maintenance (Data Management Plan, Data Management Report etc.). Databases designing, development and maintenance. Training to users involved in the study management (Investigators, CRAs, Project Managers etc). Data cleaning activities. Ensuring quality of data by establishing and administering of guidelines and standards for data management (CDISC, STDM etc.). Electronic-CRF development, testing and validation, edit checks programming. Maintain, develop, test and validation systems and processes.

  • Data Manager and Clinical Research Associate
    July 2006 --- June 2008

  • Data Manager
    January 2004 --- January 2006
    In charge for data management activities, as well as statistical analysis.

  • Account Manager
    January 2003 --- January 2003
    Account manager for Business Intelligence solutions.

Knowledge

LinkedIn Assessment :
Clinical trialsData ManagementCDISCCROClinical Data ManagementClinical researchSperimentazioni clinicheFDAGestione dei datiProtocolDatabasesCRF designEDCGCPGestione dei dati cliniciSOPClinical monitoringProgrammingTestingPharmaceuticalsUser Acceptance TestingValidazione dei sistemi informaticiProgrammazione SAS

Education

  • Master in from Università degli Studi di Milano in 2007
  • Master in from Università degli Studi di Pavia in 2002
  • Bachelor of Science in from Università degli Studi di Pavia in 2001

Area / Region

Milan, Italy

Others

Driving License
  • Yes