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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.

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 DevelopmentR&DBiotechnologymanagementRegulatory 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