Middle (2-5 years), Senior (5-10 years), Executive (>10 years)
This job can be done remotely
English - Medium
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 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
- 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.
- Medical Doctor degree, specialization in oncology and board certification in oncology
- 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 Oncology 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.