Medical Monitor (Infectious Diseases)

PSI Medical Monitors provide medical input to global clinical studies and advise the teams and business partners, while always focusing on patients' safety and well-being.

Full-time office-based in Banja Luka

Responsibilities:

• Advise clients, project teams, sites, 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
•  Provide support to medical data review
• Participate in bid defense meetings and proposal activities
• Assist in Pharmacovigilance activities
• Identify trial risks, and create and implement mitigation strategies together with other relevant departments
• Ability to organize and lead clinical development advisory boards and safety monitoring boards
• Ensure Study team compliance with FDA, EMEA, ICH and GCP guidelines