Medical Monitor, Gastroenterologist

🔥 1 minute ago

🇲🇽 Mexico – 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 • 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 • 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 medical monitoring documents • Manage trial risks related to medical monitoring • Perform ongoing medical review of clinical trial databases • Review protocol deviations and safety reports; write or review SAE narratives • Support Pharmacovigilance with safety queries and site safety issues • Review IND/SUSAR safety reports and annual IND reports • Participate in trial-related committees, including IDMC and adjudication committees • Support Pharmacovigilance, Medical Data Review, and Data Management with database reconciliation • 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 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 • Minimum of 10 years of experience practicing Gastroenterology • Clinical Research experience preferred • Proficiency with MS Office applications • Communication, presentation, and analytical skills • Problem-solving, team, and detail-oriented abilities

🏖️ Benefits

• Remote work / home-based position in Mexico • Opportunity to join PSI’s international Medical Monitoring team • Career development on the frontline of medical science • Opportunity to contribute expertise to bringing new medications to patients

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