ppPSI is a leading Contract Research Organization (CRO) with 30 years of experience in the pharmaceutical industry. Originated in Switzerland, PSI is a privately owned, full-service CRO with a global reach, supporting clinical trials across multiple countries and continents. Our reputation for being highly selective about the projects we undertake highlights our commitment to delivering high-quality, timely services across a broad spectrum of therapeutic indications. /p pAt PSI, we foster an environment where a diverse range of colleagues feel welcomed and valued. Our inclusive culture is a cornerstone of our success, enabling us to attract and retain top talent globally. /p pWe are not just about conducting clinical trials; we are about building a community where every team member has the opportunity to thrive and contribute to groundbreaking advancements in the pharmaceutical industry. /p h3Job Description /h3 pAs 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 that need them. /p pbHybrid in Madrid or Barcelona, or remote elsewhere in Spain /b /p pPSIbMedical Monitors /bprovide medical input to general clinical studies and advise the teams and business partners, while always focusing on patients' safety and well-being. /p pbResponsibilities: /b /p ul liServe 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 /li liAdvise clients, project teams, sites,



regulatory agencies and third-party vendors on medical matters /li liCollaborate with internal departments in the preparation of clinical development plans, protocols, investigator brochures, annual reports, clinical study reports, patient narratives, and scientific presentations /li liReview and analyze of clinical data to ensure the safety of study participants /li liEnsure 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 /li liAddress safety issues across the trial from sites and the study team /li liProvide support for medical data review /li liParticipate in bid defense meetings and proposal activities /li liAssist in Pharmacovigilance activities /li liIdentify trial risks, and create and implement mitigation strategies with other relevant departments /li liOrganize and lead clinical development advisory boards and safety monitoring boards /li liEnsure Study team compliance with FDA, EMEA, ICH and GCP guidelines /li /ul h3Qualifications /h3 ul liGastroenterologyFellowship certification is a must /li liPrior experience as a practicing MD (minimum of 10years) /li liPrior research and/or clinical trial industry experience is a plus /li liFull working proficiency in English /li liProficiency with MS Office applications /li liCommunication, presentation and analytical skills /li liAble to work in teams, problem‑solving, and detail‑oriented /li /ul h3Additional Information /h3 pAs 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 /p #J-18808-Ljbffr

📌 Medical Monitor (Gastroenterology) (Madrid)
🏢 Psi Cro
📍 Madrid