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Summary

creative, open-minded and flexible, i focus on finding ways to improve our daily business, thus providing a quality service to our customers and patients. process improvement initiatives should be at the basis of our daily work: any given process can be streamlined and improved - "change" is necessary to work in our very challenging environment. the management of nbe / nce supplies for Clinical trials (Phase I -> iv) poses a major challenge, that is to supply materials in a timely manner with a forecast which often changes over-night, due to external factors we have little control over: when you succeed in spite of all of these uncertainties, it is simply great!

Experiences

Current Experience

  • Head of Clinical Trial Supply Operations


    Since December 2012
    lead the Clinical Trial supplies team and support the ucb portfolio clinical study execution by providing quality Clinical Trial materials on-time and cost effectively through strong working relationship with new meds, Clinical Development and gma. Lead the Clinical Trial Supplies team and support the UCB portfolio clinical study execution by providing quality clinical trial materials on-time and cost effectively through strong working relationship with New Meds, Clinical Development and GMA.

Past Experience

  • Associate Director, Clinical Trial Supply Chain

    January 2005 --- November 2012
    from jan-2005 through nov-2012, i headed the Clinical Trial Supply Chain department, composed of 4 units (Customer Service, import / export, warehouse and cts Packaging) - this is a summary of our tasks: - manage nbe and nce supplies for Clinical trials (Phase I -> iv, including compassionate and named-patient supplies) - act as interface between Clinical operations, Regulatory Affairs and Quality Assurance - propose and develop patient kit Presentations based on the study synopsis - develop suitable product labels (single-panel, wrap-around, booklet) according to study needs and country requirements - plan and order all materials required to prepare patient kits (Packaging materials, Pharmaceutical products, diluents, comparators, ancillaries) - run the Packaging unit in a flexible way, according to cGMP, while supplying clinical material according to agreed timelines - consolidate Clinical Trial supply forecasts - maintain an electronic database of all supplies delivered and run queries for internal customers (Regulatory Affairs, Clinical operations, Quality Assurance, Biostatistics, tax department) - review internal processes and constantly work on process improvement initiatives - organize drug shipments to depots and perform direct distribution to clinical centers in the eu; review datalogger printouts and release shipments - coordinate the development of validated shippers based on the product profile and select proper dataloggers and datalogger settings - set department kpi’s

  • CTS Plant Manager

    June 1997 --- June 2003

  • Corporate R&D Materials Manager

    March 1993 --- June 1997

Knowledge

LinkedIn Assessment :
Change ManagementCustomer ServiceDatabase DesignLeadershipLotus NotesMaterialsOrganizationProblem SolvingSourcingClinical trialsGMPRegulatory affairsClinical researchQuality AssuranceClinical DevelopmentPharmaceutical IndustryDrug DevelopmentBiotechnologymanagementRegulatory submissionsCROGXPGCPFDASOP

Education

  • Post-diploma in Languages from Scuola Superiore Interpreti e Traduttori in 1979

Area / Region

Rome, Metropolitan City of Rome, Italy

Others

Driving License
  • No

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