Priscila Mattioli

Experience

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  Altana Pharma

  Nov 2000 - Aug 2007

  Monitoring conducted in accordance with the protocol, company specific policies and guidelines, Good Clinical Practice and all applicable Regulatory Requirements in Studies phase III and IV;Study Site Selection;Review of Financial Agreements;Submission of Protocol to Ethics Committe and Regulatory Authorities;Tefeconferences and frequent contacts with International Study Managers at Headquarter;Generation, review and approval of Study Documents (Informed Consent, Patient Information Booklets);Organization of Investigator´s meeting;Train study site personnel, as applicable. Show less

  • Clinical Research Coordinator

    Nov 2006 - Aug 2007

  • Clinical Research Associate

    Aug 2002 - Oct 2006

  • Pharmacovigilance & Scientific Documentation Analyst

    Dec 2001 - Jul 2002

  • Scientific Documentation Analyst

    Nov 2000 - Jul 2002
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  Nycomed

  Sept 2007 - Sept 2011

  Clinical Research Coordinator

  Full Clinical Trial Management;Managing Clinical Research Associates, ensure staff performs tasks within scope, timelines and budget;Planing, organization and conduct of trainings for Clinical Research Associate, Study Assistent, Investigators and Site staff in study procedures and responsibilities, and all applicable legal, local and ethical requirements as well as company specific policies and guidelines;Co-monitoring Visits and other related QA activities;Clinical trial site and team relationship management. Show less

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  Takeda Pharmaceuticals

  Oct 2011 - Jul 2015

  Clinical Research & Scientific Documentation Coordinator

  Clinical Trial Management - Managing all aspects and controlling of all specific requirements of a clinical trial over 800 patients from protocol design to close-out activities;Budgets forecast, preparation and review;Key link between CRO and Industry for local and corporate trials;Trial planning and start up, including regulatory phase, supplies & devices shipment;Extensive experience in negotiation of Clinical Trial Agreement with Third Parties;QA activities, including but not limited to audit preparations (office and study site);Establish goals and objectives for each study personnel and monitor their performance in agreement with Key Performance Indicators (KPIs);Line Management of Clinical Research Associates by performing co-MV as well as conducting periodic review of deliverables, assessment of KPIs to identify performance trends;Coordination the scientific documentation team in order to ensure all medical requests are answering properly. Show less

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  In career transition supported by Lee Hecht Harrison

  Aug 2015 - Sept 2015

  Clinical Team Manager, Clinical Trial Manager, Clinical Lead, Clinical Operations Manager
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  ICON plc

  Oct 2015 - now

  Clinical Trial Manager

  ICON Strategic Solutions - Contracted Partner of AMGEN.Actively working with the Development Feasibility Manager on country and site selection in Argentina, Brazil and Chile since Jan2023.Manage activities related to the planning, protocol design, review/approval, implementation, and close-out of Local Studies, Investigator Sponsored Studies, Expanded Access, Post Trial Access and Bioequivalence Studies.Manage the provision of Investigational Product referred as Post Trial Access to subjects once finish a clinical trial according to country-specific regulatory requirements in LATAM region.Ensuring identification of clinical trials needs (Ph I – PK/PD or Ph III) on Business Development projects supporting local pipeline or wishing list.Partnering and engagement with Therapeutic Area/Medical staff to ensure timely and appropriate support of deliverables.Countries supported: Argentina, Brazil, Colombia & Mexico. Oversight vendors. Show less