Medical Monitor (Gastroenterology)
Found in: beBee S CZ
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.
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
- 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
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.
22 hours ago
Prague, Hlavní město Praha, Czech Republic
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