About the job
Join our esteemed Medical Monitoring team at PSI and become a pivotal part of a global network of medical professionals dedicated to advancing medical science. Leverage your expertise to facilitate the introduction of innovative medications to patients in need.
Key Responsibilities:
- Provide expert guidance to clients, project teams, clinical sites, data safety monitoring boards, regulatory agencies, and third-party vendors on medical-related issues.
- Work collaboratively with internal departments to develop clinical development plans, protocols, investigator brochures, annual reports, clinical study reports, manuscripts, and various scientific presentations.
- Conduct thorough reviews and analyses of clinical data to safeguard the well-being of study participants throughout clinical trials.
- Ensure the accuracy, completeness, and verifiability of reported data, and confirm compliance with approved protocols and amendments.
- Tackle safety concerns raised by sites and the study team effectively.
- Engage in bid defense meetings to secure project agreements.
- Support Pharmacovigilance activities to monitor drug safety.
- Identify program risks and collaborate with Clinical Operations to develop and implement effective mitigation strategies.
- Organize and lead clinical development advisory boards and safety monitoring boards.
- Ensure compliance with local regulatory agencies, ICH, and GCP guidelines across the study team.
- Review and approve clinical documents for medical relevance.

