Medical Monitor (Infectious Diseases or Gastroenterology)

☞ PSI CRO

Aussicht: 144

Update Tag: 07-10-2024

Ort: Munich Bavaria

Kategorie: Pharma / Chemie / Biotechnologie Apotheker / Pharmavertreter

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Jobinhalt

Company Description


PSI is a leading Contract Research Organization with more than 25 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.


Job Description


PSI Medical Monitorsprovide medical input to global clinical studies and advise the teams and business partners, while always focusing on patients’ safety and well-being.

Home-Based or office based in Germany

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 different scientific presentations
  • Review and analysis of clinical data to ensure the safety of study participants in clinical studies
  • Ensure that the 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.

Qualifications
  • Medical Doctor degree
  • Infectious Diseases or Gastroenterology Fellowship certification is a must
  • Prior and wide experience as a practicing MD (minimum of 10 years)
  • Full working proficiency in English and local language
  • Proficiency with MS Office applications
  • Communication, presentation and analytical skills
  • Problem-solving, team and detail-oriented

Additional Information


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 that need them.

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Frist: 21-11-2024

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