Job DescriptionPSI 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 mattersCollaborate with internal departments in the preparation of clinical development plans, protocols, investigator brochures, annual reports, clinical study reports, manuscripts, and different scientific presentationsReview and analysis of clinical data to ensure the safety of study participants in clinical studiesEnsure that the reported data is accurate, complete, and verifiable, and that the conduct of the trial is in compliance with the currently approved protocol/amendmentsAddress safety issues across the study from sites and the study team Provide support to medical data reviewParticipate in bid defense meetings and proposal activitiesAssist in Pharmacovigilance activitiesIdentify trial risks, and create and implement mitigation strategies together with other relevant departmentsAbility to organize and lead clinical development advisory boards and safety monitoring boardsEnsure Study team compliance with FDA, EMEA, ICH and GCP guidelinesQualificationsMedical Doctor degreeInfectious Diseases Fellowship certification is a mustPrior and wide experience as a practicing MD (minimum of 10 years)Full working proficiency in EnglishProficiency with MS Office applicationsCommunication, presentation and analytical skillsProblem-solving, team and detail-oriented