BinhHoangPharm.D, MBA

Summary

• I am currently a part of NIH Covid-19 Research team. I have been involved heavily with both the Remdesivir and Moderna Phase 1 studies.
  
  
  Over 18 years of experience in Clinical Trial Management - Expertise areas include:
  • Knowledge of Export and Import pharmaceutical product regulations and requirements
  • Directly contact pharmaceutical manufacturers on behalf of sponsor to obtain study products for NIH sponsored HIV clinical trials.
  • Familiar with Harmonized Tariff Schedule Codes and Export Commodity Classification
  • Contributed to researching and developing a Guide for Importing Pharmaceutical Regulations (for clinical trials) for 20 countries
  • Manage and deal with customs broker and freight forwarders
  • Respond and interact with FDA’s, DEA’s and other government’s requests
  • Experience working with 300 clinical sites in 20 countries
  • Experience in writing government contract proposals - Review and analyze the requirements of the solicitation. Research, write and edit materials for proposal.
  • Develop and implement Standard Operational Practices (SOPs)
  • Serve as primary liaison to clinical site pharmacists in 20 countries
  • Clinical trial experience – knowledge of design and implementation of clinical trials
  • Clinical supplies distribution for HIV clinical trials.
  • Evaluate and analyze HIV clinical trial protocols
  • Forecast study supply for protocols
  • Knowledge of Good Clinical Practice guidelines