About the job
Join the esteemed Medical Monitoring team at PSI, where you will be an integral part of our global community of medical professionals. This is an opportunity to advance your career at the cutting edge of medical science, utilizing your expertise to help deliver innovative therapies to patients in need.
Office locations available: Tokyo or Osaka.
Key Responsibilities:
- Provide expert medical advice to clients, project teams, clinical sites, data safety monitoring boards, regulatory bodies, and third-party vendors.
- Work collaboratively with cross-functional teams to develop clinical plans, protocols, investigator brochures, and study reports.
- Conduct thorough reviews and analyses of clinical data to safeguard the well-being of study participants.
- Ensure that all reported data is precise, comprehensive, and verifiable, complying with the approved protocols and amendments.
- Proactively address safety concerns from clinical sites and study teams.
- Engage in bid defense meetings to secure new projects.
- Support Pharmacovigilance initiatives.
- Identify potential risks within programs and collaborate with Clinical Operations to implement effective mitigation strategies.
- Organize and lead clinical development advisory boards and safety monitoring boards.
- Guarantee compliance with local regulatory standards, ICH, and GCP guidelines within the study team.
- Review and approve clinical documents for medical relevance.

