Medical Monitor (Board-certified, Internal Medicine)
2 months ago
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 s.....
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.
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
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