Medical Monitor (Gastroenterology)

As part of PSIs 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.

Full-time employment Office location: Tokyo or Osaka

Responsibilities:

• Advise clients project teams sites data safety monitoring boards regulatory agencies and third-party vendors on medical matters
• Collaborate with internal departments in the preparation of clinical development plans protocols investigator brochures annual reports clinical study reports manuscripts and different scientific presentations
• Review and analysis of clinical data to ensure the safety of study participants in clinical studies
• Ensure that the reported data is accurate complete and verifiable and that the conduct of the trial is in compliance with the currently approved protocol/amendments
• Address safety issues across the study from sites and the study team
• Participate in bid defense meetings
• Assist in Pharmacovigilance activities
• Identify Program risks and create and implement mitigation strategies with Clinical Operations
• Ability to organise and lead clinical development advisory boards and safety monitoring boards
• Ensure Study team compliance with local regulatory agencies ICH and GCP guidelines
• Review and sign off clinical documents with respect to medical relevance

Qualifications :

• Medical Doctor degree
• Board-certification in Gastroenterology is preferred
• Clinical experience in major therapeutic area (Oncology Infectious disease Gastroenterology Hematology Internal Medicine) is desirable
• Prior experience in Clinical Research.
• Familiar and comfortable with clinical concepts practices and local regulations regarding clinical research trials experience with local health authority interactions leading to drug approval strongly preferred
• Ability to interact with and train clinical monitors and physician investigators and build constructive trusting and respectful relationships with colleagues at all levels within and outside the organization
• Must possess excellent leadership communication presentation and organizational skills and be able to exercise sound critical thinking and problem-solving skills and execute position responsibilities with minimal guidance
• Proficiency with MS Office applications

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.

Remote Work :

No

Employment Type :

Full-time

Experience: years
Vacancy: 1