Amanda P Roepke

Experience

• 

  PPD

  Jan 2006 - Mar 2006

  Clinical Regulatory Specialist

  Implemented and coordinated rapid study start-up, interim and closeout activities associated with clinical trials to ensure applicable timelines and metrics are met, including all regulatory, legal and financial aspects in accordance with FDA GCPs, ICH Guidelines and Global SOPsAccountable for meeting applicable project timelines in accordance with the Master ContractLiaison with Legal department to ensure Clinical Study Agreements are finalized and filed appropriatelyProject Assistant (2004-2006)• Provided day-to-day administrative support/clerical support to the team• Maintained central study files for assigned projects• Responsible for regulatory review in accordance with FDA, GCP, WPD and SOPs• Assisted with the identification of potential investigator and development of initial protocol packets• Trained and mentored new Research Assistants for the department Show less

• 

  IQVIA

  Oct 2008 - Nov 2020

  Mentoring and TrainingClinical Administrative Support Special ProjectsMetric ReportingCTA Business Process DocumentationData Transfer Team Lead

  • Site Manager I

    Apr 2015 - Nov 2020

  • Clinical Project Specialist

    Oct 2012 - Apr 2015

  • Senior Clinical Trials Assistant

    Oct 2008 - Sept 2012
• 

  MedAvante-ProPhase

  Nov 2020 - now

  Associate Project Manager