Medical Monitor (Gastroenterology)

Company Description:PSI 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.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.Full-time employment based in SpainResponsibilities: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 guidelinesAdvise 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, patient narratives, and scientific presentationsReview and analysis of clinical data to ensure the safety of study participants in clinical trialsEnsure 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/amendmentsAddress safety issues across the trial from sites and the study teamProvide support for medical data reviewParticipate in bid defense meetings and proposal activitiesAssist in Pharmacovigilance activitiesIdentify trial risks, and create and implement mitigation strategies with other relevant departmentsOrganize and lead clinical development advisory boards and safety monitoring boardsEnsure Study team compliance with FDA, EMEA, ICH and GCP guidelinesQualifications:Medical Doctor degreeGastroenterology Fellowship certification is a mustPrior experience as a practicing MD (minimum of 10 years)Prior research and/or industry experience is a plusFull working proficiency in EnglishProficiency with MS Office applicationsCommunication, presentation and analytical skillsAble to work in teams, problem-solving, and detail-orientedAdditional Information:As 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.