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Summary

Clinical Trial specialist with experience in Clinical Development, Clinical operations, Data Management and Statistics. i have knowledge in managing and conducting national and international multicentre Phase I, ii, iii and iv clinical studies on drugs and Medical Devices. i collaborated with some international and italian Pharmaceutical industries and contract Research organizations.

Experiences

Current Experience

  • Clinical Research Associate (Consultant)


    Since January 2014
    running Clinical trials on Medical Devices in Neurology area, managing sites in italy and switzerland (canton ticino). i am involved in all stages of the trial, including ec submissions, setting up, initiating, monitoring and closing down the trial. Running clinical trials on medical devices in neurology area, managing sites in Italy and Switzerland (Canton Ticino). I am involved in all stages of the trial, including EC submissions, setting up, initiating, monitoring and closing down the trial.

  • Clinical Research Associate (Consultant)


    Since February 2013
    monitoring of Clinical studies in cardiovascular area. Monitoring of clinical studies in cardiovascular area.

  • Zintro Expert


    Since January 2012
    Consulting on Electronic Data Capture (edc). Consulting on electronic data capture (EDC).

  • Clinical Development Consultant


    Since January 2011
    my responsibilities involve clinical and Statistical activities related to clinical studies on Medical Devices: Planning of Clinical Trial development defining timeline and feasibility of Clinical trials from early stages (proof of concept) to Phase III trials; writing protocols and plans related to Clinical Development and management; contacting clinicians and researchers for both collaborate in developing protocols and evaluate interest in participation in Clinical trials; selecting vendors for both clinical and Data Management activities. My responsibilities involve clinical and statistical activities related to clinical studies on medical devices: planning of clinical trial development defining timeline and feasibility of clinical trials from early stages (proof of concept) to phase III trials; writing protocols and plans related to clinical development and management; contacting clinicians and researchers for both collaborate in developing protocols and evaluate interest in participation in clinical trials; selecting vendors for both clinical and data management activities.

Past Experience

  • Regional CRA (Consultant)

    November 2013 --- October 2015

    monitoring oversight activities for Phase I/iii protocols on hemophilia in italy.

  • Regional Study Manager - EMEA Region

    February 2015 --- September 2015
    my responsibilities were: to contribute to Clinical operational Planning activities and managing study execution in emea region; to providie oversight to the external service provider(s) to ensure quality standards are being met and for developing positive study site relationships; to ensure Communication and effective working relationships with external service providers and study sites; to ensure preventive/ corrective action(s) are implemented to address regional/country level issues; to participate in the study execution team, as appropriate; to provide input into study timelines, study budget, and support the on-time delivery of a Clinical study in their region.

  • Clinical Research Associate (Consultant)

    September 2014 --- September 2015
    running Clinical trials on Medical Devices in italy, being involved in all stages of the trial, including ec submissions, setting up, initiating, monitoring and closing down the trial.

  • Statistician (Consultant)

    July 2012 --- February 2015
    Statistical Analysis of data from Clinical trials. writing of Statistical sections of published papers.

  • Clinical Research Associate (Consultant)

    July 2013 --- December 2013
    monitoring of Clinical studies using Medical Devices in Respiratory area.

  • Statistician (Consultant)

    January 2012 --- June 2012
    supervision and coordination of Statistical activities related to phase 1 Clinical studies, from the preparation of the science)" rel="nofollow">Protocol to the draft of the final report.

  • Clinical Research & Statistics Responsible (Consultant)

    November 2009 --- June 2012
    definition of the employment contracts with consultants. contacts with sponsors to define contracts, procedures and monitoring plan. supervision and coordination of Clinical and Statistical activities related to Clinical studies, from the preparation of the science)" rel="nofollow">Protocol to the draft of the final report. implementation of an Electronic Data Capture (edc) system based on SAS pheedit and using CDISC standards.

  • Clinical Research Associate II (Consultant)

    February 2011 --- February 2012
    support to CRA in monitoring visit activities. selection of Clinical sites by pre-study visits.

  • Statician (Consultant)

    March 2010 --- July 2010
    Data Analysis and preparation of Clinical study reports for Clinical trials. writing of Statistical sections of published papers.

  • Data Management Responsible (Consultant)

    February 2008 --- February 2010
    reorganization of the structure of Data Management and implementation of an Electronic Data Capture (edc) system based on oracle and using CDISC standards.

  • Satistician (Consultant)

    November 2006 --- November 2009
    preparation of the Statistical section of the Clinical Trial protocols, Statistical analysis plan realization, Data Analysis and preparation of Clinical study reports for Clinical trials.

  • Clinical Research & Statistics Responsible (Consultant)

    April 2008 --- October 2009
    definition of the employment contracts with consultants. contacts with sponsors to define contracts, procedures and monitoring plan. supervision and coordination of Clinical and Statistical activities related to Clinical studies, from the preparation of the science)" rel="nofollow">Protocol to the draft of the final report.

  • Statistician (Consultant)

    March 2007 --- March 2009
    Data Analysis and preparation of Statistical reports.

  • Clinical Research Consultant

    January 1995 --- March 2008
    monitoring of clinical studies in asthma, cardiovascular, migraine and oncology areas (smithkline beecham; zeneca/astrazeneca; sanofi-aventis). Clinical Data Management of clinical studies (chiesi; merck; roche; sanofi-aventis; zeneca/astrazeneca). drafting of clinical and biometric Validation guidelines. drafting of standard operative procedures. drafting of Statistical reports for Clinical trials. Teaching on Statistics and data management.

  • Statistician (Consultant)

    January 1993 --- January 1995
    Analysis of Marketing data

  • Pharmacologist

    January 1983 --- January 1993
    pharmacological screening of antiulcer/antisecretory and anti-inflammatory compounds. pharmacological development of compounds on gastrointestinal, inflammatory and allergy areas. development of a project for Testing pharmacological activity of new delivery system for anti-inflammatory drugs. implementation of Standard Operating Procedure for Research laboratories, according to Good Laboratory Practice.

Knowledge

LinkedIn Assessment :
Clinical trialsoncologyEDCClinical DevelopmentClinical Data ManagementClinical researchData ManagementBiostatisticsPharmaceutical IndustryCROMedical writingProtocolSOPpharmacologyGood Laboratory Practice (GLP)GCPMedical Devices

Education

  • M. Sc. in Biology from Università degli Studi di Milano in 1981
  • Degree in Industrial Chemistry from Istituto Tecnico Chimica Industriale E. Molinari in 1976
  • in from Coursera in 0000

Training and Certification

  • Clinical Research Associate in 0000 Certification
  • Experienced Clinical Research Associate in 0000 Certification

Languages

BrightOwl Assessment:
Self Assessment:
Italian
Native
English
Professional Proficiency

Work Preferences

  • Positions I am interested in:
    Clinical Project Manager (CPM) Senior Clinical Research Associate (CRA) Clinical Research Consultant
  • Locations I am interested in:
    Italy Switzerland
  • Work From Home:
    Yes, 0 to 5 days per week
  • Work Regime:
    BrightOwl freelancer :    20-40 Hours per week
  • International:
    Yes

Area / Region

Italy

Others

Driving License
  • Yes

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