Alexander Meier

About Alexander Meier

A licensed healthcare professional pharmacist practicing as a clinical research…

Experience

1. Clinical Research Specialist (Clinical Trial Manager)

   Johnson & Johnson

   Nov 2022 — Present

   Oversee Clinical Research Organizations (CROs) and Clinical Research Associates (CRAs)• Assist the CRO CRAs during Interim Monitoring Visits (IMVs). Going on-site when needed, building strong relationships with site personnel, and maintaining successful enrollment and participation in the clinical trial• Participate in the Premarket Approval (PMA) submission to the U.S Food and Drug Administration (FDA)• Internal sponsor audit participant responsible for electronic Trial Master File (eTMF) preparation and audit readiness• Manage various clinical research sites around the country as the assigned site manager• Review and approve regulatory Study Article Release Greenlight Forms for Primary Investigator (PI) changes and site activation• Complaints Handling Unit (CHU) point of contact for product investigation report and customer letter reconciliation with the Electronic Data Capture (EDC) system, iMedidata• Ensure that trials adhere to study protocols, applicable SOPs, FDA regulations, International Conference for Harmonization (ICH)/ Good Clinical Practices (GCP) guidelines, and government regulations• Exercise clinical judgment, emotional intelligence, and demonstrate professional conduct when interacting with PIs and Clinical Research Coordinators (CRCs)

Education

• The University of Findlay

  Doctor of Pharmacy - PharmD

  2015 — 2020