Medical Monitor / Associate Director (Gastroenterology)
Bucharest, Romania
1 zi în urmă

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 Monitors provide medical input to global clinical studies and advise the teams and business partners, while always focusing on patients' safety and well-being.

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.


  • Provide medical monitoring to clinical project teams and sites including out of hours coverage
  • Collaborate with Project Management, Clinical Operations and other departments in the preparation of clinical development plans, protocols, investigator brochures, clinical study reports,
  • Responsible for review and analysis of clinical data including safety monitoring
  • Provide medical trainings to the project teams and sites
  • Medical review of the SAEs narratives, prepare SAE queries
  • Organize and lead data monitoring / safety monitoring committees
  • Participate in BID defense, Kick-off meetings, Investigator’s Meeting (prepare and deliver presentations)
  • Participates in project risk assessment activities
  • Qualifications

  • MD degree, Specialization in internal medicine / gastroenterology , board certification in internal medicine / gastroenterology is a plus
  • Previous experience in medical practice / patient care
  • Prior experience in clinical research and review / interpretation of medical records
  • Knowledge of the safety review process, medical terminology, coding dictionaries and safety regulatory requirements
  • Strong knowledge and experience with oncology trials / with trials in internal medicine / gastroenterology trials
  • Full working proficiency in English
  • Proficiency with MS Office applications
  • Communication, presentation and analytical skills
  • Problem-solving, team and detail-oriented
  • Additional Information

    Join our highly dedicated team of clinical research professionals with +250 Medical Doctors onboard, and make a tangible difference within a professional and energetic organization founded by scientists.

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