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PSPSI CRO

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

Wien
from 80,000 / year
Full-timeWith Home OfficeSenior

Medical oversight for global GI clinical trials, advising teams and sponsors on patient safety. Gastroenterology fellowship and 10+ years MD experience required. Research experience a plus, with 6 weeks vacation.

Requirements

  • Medical Doctor degree
  • Gastroenterology Fellowship certification
  • Minimum 10 years practicing MD experience
  • Research and/or industry experience (plus)
  • Full working English proficiency
  • MS Office applications proficiency
  • Communication, presentation, and analytical skills
  • Teamwork, problem-solving, detail-oriented

Tasks

  • Provide medical input to global clinical studies
  • Advise teams and business partners on medical matters
  • Focus on patient safety and well-being
  • Serve as medical point of contact for internal teams, study sites, and sponsors
  • Advise clients, project teams, sites, regulatory agencies, and vendors on medical matters
  • Collaborate on clinical development plans
  • Collaborate on protocols
  • Collaborate on investigator brochures
  • Collaborate on annual reports
  • Collaborate on clinical study reports
  • Collaborate on patient narratives
  • Collaborate on scientific presentations
  • Review and analyze clinical data for participant safety
  • Ensure trial data is accurate, complete, and verifiable
  • Ensure trial conduct complies with approved protocol/amendments
  • Address safety issues across the trial from sites and study teams
  • Support medical data review
  • Participate in bid defense meetings
  • Participate in proposal activities
  • Assist in pharmacovigilance activities
  • Identify trial risks
  • Create mitigation strategies
  • Implement mitigation strategies with relevant departments
  • Organize clinical development advisory boards
  • Lead clinical development advisory boards
  • Organize safety monitoring boards
  • Lead safety monitoring boards
  • Ensure study team compliance with FDA, EMEA, ICH, and GCP guidelines

Work Experience

  • 10 years

Education

  • Bachelor's degree

Languages

  • EnglishBusiness Fluent

Tools & Technologies

  • MS Office

Benefits

Other Benefits

  • Excellent working conditions

Learning & Development

  • Extensive training

Informal Culture

  • Friendly team

Mentorship & Coaching

  • Personal and professional growth opportunities
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of PSI CRO and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.

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