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.
Hybrid based position in Sofa, Bulgaria
Responsibilities:
- Serve as medical point of contact for internal project team, study sites and study sponsor for medical matters related to the conduct of clinical trials per protocol and per GCP guidelines
- 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, patient narratives, and scientific presentations
- Review and analysis of clinical data to ensure the safety of study participants in clinical trials
- Ensure that the reported trial 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 trial from sites and the study team
- Provide support for medical data review
- Participate in bid defense meetings and proposal activities
- Assist in Pharmacovigilance activities
- Identify trial risks, and create and implement mitigation strategies with other relevant departments
- Organize and lead clinical development advisory boards and safety monitoring boards
- Ensure Study team compliance with FDA, EMEA, ICH and GCP guidelines