Medical Monitor, Gastroenterologist

🔥 18 minutes ago

🇧🇷 Brazil – 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 point of contact for trial-specific medical and safety-related questions • Provide input for regulatory authority and IRB/IEC responses • Monitor trial participant safety • Support 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 within medical monitoring scope • Manage ongoing trial risks related to medical monitoring • Perform ongoing medical review of operational clinical trial databases and support Medical Reviewers • Review protocol deviations, RAE reports, SAE narratives, safety reports, essential trial records, and annual IND reports • Support Pharmacovigilance with safety queries and interact with sponsors on site safety issues • Participate in independent data monitoring and adjudication committees • Support reconciliation of safety and operational clinical trial databases • Review clinical study reports, including safety narratives and TFLs • Provide medical expertise on an as-needed basis • Prepare for and participate in trial audits and follow up on audit findings • Participate in feasibility assessments for trials in the country/region • Participate in bid defense meetings and client interactions • 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 Portuguese • Proficiency with MS Office applications • Communication, presentation and analytical skills • Problem-solving, team and detail-oriented

🏖️ Benefits

• Stability and innovation through PSI’s established CRO environment • Opportunity to build a career on the frontline of medical science • Opportunity to use medical expertise to help bring new medications to patients

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