Medical Monitor, Gastroenterologist

🔥 18 minutes ago

🇦🇷 Argentina – Remote

⏰ Full Time

🟠 Senior

🔴 Lead

🧪 Clinical Research

👻 Ghost score 10%

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PSI CRO AG

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1996

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

PSI CRO AG is a global contract research organization (CRO) that specializes in conducting clinical trials. The company focuses on delivering pivotal Phase 2 and 3 clinical trials across various therapeutic areas, including Inflammatory Bowel Diseases, Oncology, Hematology, Infectious Diseases, Multiple Sclerosis, and Rare Diseases. PSI utilizes a proprietary technology platform for clinical trial planning and financial tracking to ensure trials are conducted on time and within budget. The company is recognized for its expertise, quality, compatibility, and reliability, having been awarded the CRO Leadership Awards for multiple consecutive years.

📋 Description

• Provide medical input to global clinical studies and advise teams and business partners, focusing on patient safety and well-being • Act as the primary contact for trial-specific medical and safety-related questions • Provide input for regulatory authority and IRB/IEC responses • Monitor trial participant safety • Participate in participant recruitment and retention activities • Present medical matters at kick-off and investigator meetings • Train trial teams on the therapeutic area and protocol medical aspects • Develop and review trial-specific documents • Manage ongoing trial risks related to medical monitoring • Conduct ongoing medical review of clinical trial databases and support Medical Reviewers • Review protocol deviations, RAE reports, SAE narratives, IND/SUSAR safety reports, and clinical study reports • Support Pharmacovigilance, Medical Data Review, and Data Management with safety and database reconciliation • Participate in trial-related committees, feasibility assessments, bid defense meetings, client interactions, audits, and follow-up on audit findings • Act as a medical expert and provide therapeutic expertise to other PSI departments

🎯 Requirements

• Medical Doctor degree required • Experience as a practicing Gastroenterologist (minimum of 10 years) • Clinical Research experience preferred • Full working proficiency in English and Spanish • Proficiency with MS Office applications • Communication, presentation and analytical skills • Problem-solving, team and detail-oriented

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