Medical Monitor Infectious Diseases H/F PSI CRO

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

Full-time employment based in France

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