Job Description
PSI Medical Officers provide medical input to global clinical studies and advise the teams and business partners, while always focusing on patients' safety and well-being. Join our 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.
Office-Based or Home-Based
Your role:
- 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 training to the project teams and sites
- Perform medical review of and follow up on incoming SAE reports including narrative content and queries
- Organize and lead data monitoring/safety monitoring committees
- Participate in BID defense, Kick-off meetings, Investigator's Meetings (prepare and deliver presentations)
- Participate in project risk assessment activities
Qualifications
- Medical Doctor degree, board certified in Internal Medicine / Gastroenterology
- Prior 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 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.
