Medical Officer (Gastroenterology)

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 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.

You will:

• Provide medical monitoring to clinical project teams and sites
• 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
• Reference: ANq5fVG4CVhugzZu8ABBsv2JlaPgsv_HurYNN8YM2y8.

Qualifications:

• Medical Doctor degree, board certified in 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
• Knowledge and experience with Gastroenterology trials is a plus
• 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.