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PS
PSI CRO
18d ago

Medical Monitor (Gastroenterology)(m/w/x)

München
Full-timeWith Home OfficeSenior

Description

In this role, you will be the key medical contact for clinical trials, ensuring participant safety and compliance with regulations. Your daily responsibilities will include advising teams, reviewing clinical data, and collaborating on development plans.

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Requirements

  • Medical Doctor degree
  • Gastroenterology Fellowship certification
  • Minimum of 10 years of experience as a practicing MD
  • Prior research and/or industry experience
  • Full working proficiency in English
  • Proficiency with MS Office applications
  • Communication, presentation, and analytical skills
  • Teamwork, problem-solving, and detail-oriented skills

Education

Bachelor's degree

Work Experience

10 years

Tasks

  • Serve as the medical point of contact for project teams, study sites, and sponsors
  • Advise clients and teams on medical matters related to clinical trials
  • Collaborate on clinical development plans and protocols
  • Review investigator brochures and annual reports
  • Analyze clinical data to ensure participant safety
  • Verify the accuracy and completeness of reported trial data
  • Address safety issues raised by sites and the study team
  • Support medical data review processes
  • Participate in bid defense meetings and proposal activities
  • Assist with pharmacovigilance activities
  • Identify trial risks and implement mitigation strategies
  • Organize and lead clinical development advisory boards
  • Ensure compliance with FDA, EMEA, ICH, and GCP guidelines

Tools & Technologies

MS Office

Languages

EnglishBusiness Fluent

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