Medical Monitor

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.

Responsibilities

• 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.