Job Description
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.
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
Qualifications
* Medical Doctor degree
* Infectious Diseases Fellowship certification is a must
* Prior and wide experience as a practicing MD (minimum of 10 years)
* Full working proficiency in English
* Proficiency with MS Office applications
* Communication, presentation and analytical skills
* Problem-solving, team and detail-oriented