Medical Monitor – Canada Board-Certified Gastroenterologist

🔥 11 minutes ago

🇨🇦 Canada – Remote

⏰ Full Time

🟠 Senior

🔴 Lead

🧪 Clinical Research

👻 Ghost score 10%

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PSI CRO AG

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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 medical and safety contact for all parties on trial-specific questions • Provide input to regulatory authorities and IRBs/IECs • 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 ongoing medical-monitoring risks • Perform ongoing medical review of operational clinical trial databases • Review protocol deviations, RAE reports, SAE narratives, IND/SUSAR safety reports, and annual IND reports • Support Pharmacovigilance, Medical Data Review, and Data Management with safety and database reconciliation • Participate in IDMC and adjudication committees • Review clinical study reports, including safety narratives and TFLs • Prepare for and participate in trial audits and follow up on findings • Participate in feasibility assessments, bid defense meetings, and client interactions • Act as a medical expert and provide therapeutic expertise to PSI departments

🎯 Requirements

• Medical Doctor degree required • Canada Board Certification in Gastroenterology required • Minimum of 10 years of experience as a practicing Gastroenterologist • Clinical Research experience preferred • Proficiency with MS Office applications • Communication, presentation, and analytical skills • Problem-solving, team-oriented, and detail-oriented • Willingness/ability to provide medical expertise for global clinical studies and related trial activities

🏖️ Benefits

• Remote work / home-based work in Canada • Full-time employment • Opportunity to join an 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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