Medical Monitor, Gastroenterologist

🔥 0 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

• Act as the primary point of contact for trial-specific medical and safety-related questions • Provide input for responses to regulatory authorities and Institutional Review Boards/Independent Ethics Committees • Monitor trial participant safety • Participate in participant recruitment and retention activities • Present medical matters at kick-off and investigator meetings • Train trial teams in the therapeutic area and protocol medical aspects • Develop and review trial-specific medical monitoring documents • Manage ongoing trial risks related to medical monitoring • Perform ongoing medical review of operational clinical trial databases • Review protocol deviations, RAE reports, SAE narratives, safety reports, trial records, and annual IND reports • Support Pharmacovigilance, Medical Data Review, and Data Management with database reconciliation and safety queries • Participate in trial-related committees, including independent data monitoring and adjudication committees • Review clinical study reports, including safety narratives and tables, figures, and listings • Prepare for and participate in trial audits and follow up on audit findings • Participate in feasibility assessments of potential and ongoing 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

• Remote work / home-based role in Brazil • International group of medical professionals • Career development on the frontline of medical science • Opportunity to use medical expertise to help bring new medications to patients

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