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Clinical Development Consultant

vor 1 Woche


Zug, Zug, Schweiz TN Switzerland Vollzeit
About the Role

This Global Clinical Study Advisor position plays a critical role in ensuring the safety and integrity of clinical studies. As a member of our Medical Monitoring team, you will work closely with clients, project teams, and regulatory agencies to provide expert medical input and advice.

Main Responsibilities:

  • Provide medical input to global clinical studies and advise on clinical development plans, protocols, and investigator brochures
  • Collaborate with internal departments to prepare clinical study reports, manuscripts, and scientific presentations
  • Review and analyze clinical data to ensure the safety of study participants
  • Verify the accuracy, completeness, and verifiability of reported data and ensure compliance with approved protocols and amendments
  • Address safety issues across the study from sites and the study team
  • Assist in Pharmacovigilance activities and identify Program risks
  • 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
  • Canada 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