Medical Science Advisor

Vor 6 Tagen

Zug, Zug, Schweiz PSI Vollzeit

Job Summary

PSI is seeking a highly skilled Medical Monitor to provide medical input to global clinical studies and advise teams and business partners on medical matters.

Key Responsibilities:

  • Advise clients, project teams, sites, data safety monitoring boards, regulatory agencies, and third-party vendors on medical matters.
  • Collaborate with internal departments in the preparation of clinical development plans, protocols, investigator brochures, annual reports, clinical study reports, manuscripts, and scientific presentations.
  • Review and analyze clinical data to ensure the safety of study participants in clinical studies.
  • Ensure that reported data is accurate, complete, and verifiable, and that the conduct of the trial is in compliance with the currently approved protocol/amendments.
  • Address safety issues across the study from sites and the study team.
  • Review listings for coded events to verify Medical Dictionary for Regulatory Activities.
  • Participate in bid defense meetings.
  • Assist in Pharmacovigilance activities.
  • Identify program risks and create and implement mitigation strategies with Clinical Operations.
  • Ability to organize and lead clinical development advisory boards and safety monitoring boards.
  • Ensure study team compliance with FDA, EMEA, ICH, and GCP guidelines.
  • Review and sign off clinical documents with respect to medical relevance.

Requirements

  • Medical Doctor degree required.
  • US Board Certification in Gastroenterology required.
  • Experience as a practicing Gastroenterologist (minimum of 10 years).
  • Full working proficiency in English.
  • Clinical Research experience preferred.
  • Proficiency with MS Office applications.
  • Communication, presentation, and analytical skills.
  • Problem-solving, team, and detail-oriented.

About PSI

As part of PSI's Medical Monitoring team, you will join our international group of medical professionals, build a career on the frontline of medical science, and use your knowledge and expertise to help bring new medications to patients who need them.

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