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PSI CROPosted 1 month ago

Medical Monitor (Gastroenterologist)

RemoteBrazil

Full TimeLargeBIOTECH

Job Summary

Conduct primary medical monitoring for gastroenterology clinical trials by acting as the point of contact for medical and safety questions, reviewing protocol deviations, and managing trial risks. Monitor participant safety, respond to regulatory authorities and IRBs, and review clinical study reports including safety narratives. Train trial teams on medical aspects of the protocol, present at investigator meetings, and support pharmacovigilance with safety queries and adverse event reporting. Participate in trial audits, feasibility assessments, and bid defense meetings while providing therapeutic expertise to other departments. Perform medical review of the operational clinical trial database and support independent data monitoring committees.

Required Qualifications

  • Medical Doctor degree
  • Experience as a practicing Gastroenterologist (minimum of 10 years)
  • Full working proficiency in English and Portuguese

Desired Qualifications

  • Clinical Research experience preferred

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