Pharmaceutical Industry Expert

5 days ago


Gainesville, Florida, United States Maxis Clinical Sciences Full time
About the Opportunity

This is a fantastic opportunity to join Maxis Clinical Sciences as a Medical Director and take on a leadership role in our clinical trials operations.

Responsibilities
  • Monitors all safety variables (AE, laboratory abnormalities, changes in patient medical status, evaluation of prescribed concomitant medication for protocol restrictions, and un-blinding requests) of clinical studies.
  • Provides medical review of adverse events of special interest, serious adverse events, and clinical outcomes events reported by study sites.
  • Performs data review as specified in the client contract and data validation manual, including review of coding listings and/or full safety data to assess for potential safety concerns.
Requirements
  • MD or equivalent required; active medical licensure preferred.
  • Candidates should have at least one of the following: clinical experience in treating patients in the specialty or sub-specialty associated with their training (comparable to 3 years), suitable clinical trial experience in a Contract Research Organization, pharmaceutical company, or as a principal investigator (comparable to 3-5 years) in the industry, or direct experience in safety/Pharmacovigilance (comparable to 3 years).


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