Medical Monitor

hace 7 días


Madrid, España PSI CRO A tiempo completo

Medical Monitor (Infectious Diseases) PSI CRO Madrid, Community of Madrid, Spain PSI is a leading Contract Research Organization (CRO) with 30 years of experience in the pharmaceutical industry, founded in Switzerland. PSI is a privately owned, full‑service CRO that supports clinical trials across multiple countries and continents, delivering high‑quality, timely services across a broad spectrum of therapeutic indications. 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 scientific presentations Review and analyse 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 and 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 Organise 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 (required) Minimum of 10 years of experience as a practicing MD Full working proficiency in English Proficiency with MS Office applications Strong communication, presentation and analytical skills Problem‑solving, teamwork and detail‑oriented mindset Additional Information Stable, privately‑owned company, organically growing since 1995 Comfortable office facilities with easy commute; opportunities to work office‑based, hybrid or remote Intensive induction program and industry‑related training for an optimal start and continuous development Friendly and supportive atmosphere in a committed team International environment, with colleagues around the world Attractive income package; performance‑based bonuses; corporate benefits Seniority level: Associate Employment type: Full‑time Job function: Research Industries: Pharmaceutical Manufacturing #J-18808-Ljbffr


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