PPSI is a leading Contract Research Organization with 30 years experience in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications. /ph3Job Description /h3pPSIstrongMedical Monitors /strongprovide medical input to global clinical studies and advise the teams and business partners, while always focusing on patients' safety and well-being. /ppstrongResponsibilities: /strong /pulliServe 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 /liliAdvise clients, project teams, sites, regulatory agencies and third-party vendors on medical matters /liliCollaborate with internal departments in the preparation of clinical development plans, protocols, investigator brochures, annual reports, clinical study reports, patient narratives, and scientific presentations /liliReview and analysis of clinical data to ensure the safety of study participants in clinical trials /liliEnsure 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 /liliAddress safety issues across the trial from sites and the study team /liliProvide support for medical data review /liliParticipate in bid defense meetings and proposal activities /liliAssist in Pharmacovigilance activities /liliIdentify trial risks, and create and implement mitigation strategies with other relevant departments /liliOrganize and lead clinical development advisory boards and safety monitoring boards /liliEnsure Study team compliance with FDA, EMEA, ICH and GCP guidelines /li /ulh3Qualifications /h3ulliGastroenterologyFellowship certification is a must /liliPrior experience as a practicing MD (minimum of 10years) /liliPrior research and/or industry experience is a plus /liliFull working proficiency in English /liliProficiency with MS Office applications /liliCommunication, presentation and analytical skills /liliAble to work in teams, problem-solving, and detail-oriented /li /ulh3Additional Information /h3pAs part of PSI's Medical Monitoring team, you will join our international group of medical professionals, build a career on the frontline of medical science and use your knowledge and expertise to help bring new medications to patients. /p #J-18808-Ljbffr