Medical Monitor (Oncology)

☞ PSI CRO AG

View: 105

Update day: 04-11-2025

Location: Leuven Flemish Brabant

Category: Other

Industry: Pharmaceutical Manufacturing

Position: Mid-Senior level

Job type: Full-time

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Job content

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.

Responsibilities:

  • Medical point of contact for internal project team, study sites and study sponsor for medical matters related to the conduct of clinical trials per protocol and per GCP guidelines
  • 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, narratives, 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
  • Supports and/or performs medical data review of the operational clinical trial database
  • Participate in meetings with clients and Investigators
  • Assist in Pharmacovigilance activities
  • Identify Program risks, and create and implement mitigation strategies with Clinical Operations
  • 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 medically relevant documents.
Qualifications

  • Medical Doctor degree
  • Oncology Fellowship certification is a must
  • Prior and wide experience as a practicing Oncologist (minimum of 10 years)
  • Full working proficiency in English
  • 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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Deadline: 19-12-2025

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