About the job
Join our esteemed Medical Monitoring team at PSI, where you will collaborate with a global network of medical professionals. This is your opportunity to advance your career at the forefront of medical science, leveraging your expertise to facilitate the introduction of innovative medications that can significantly improve patients' lives.
Key Responsibilities:
- Provide expert medical advice to clients, project teams, clinical sites, data safety monitoring boards, regulatory authorities, and third-party vendors.
- Work alongside various internal departments to develop comprehensive clinical development plans, study protocols, investigator brochures, annual reports, clinical study reports, manuscripts, and scientific presentations.
- Conduct thorough reviews and analyses of clinical data to safeguard the well-being of study participants.
- Verify the accuracy, completeness, and verifiability of reported data, ensuring adherence to the approved protocol and amendments.
- Proactively address safety concerns arising from clinical sites and study teams.
- Engage in bid defense meetings to secure project proposals.
- Support Pharmacovigilance initiatives.
- Identify potential program risks and collaborate with Clinical Operations to devise and implement mitigation strategies.
- Lead and organize clinical development advisory boards and safety monitoring boards.
- Ensure compliance of the study team with local regulatory agencies, ICH, and GCP guidelines.
- Review and approve clinical documents for medical relevance.

