Medical Monitor – Gastroenterologist

🔥 5 hours ago

🇲🇽 Mexico – Remote

⏰ Full Time

🟠 Senior

🔴 Lead

🧪 Clinical Research

👻 Ghost score 10%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

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 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 trial risks related to medical monitoring • 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 database reconciliation • Participate in trial-related committees, including 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 of potential and ongoing trials • Participate in bid defense meetings and client interactions • Provide therapeutic expertise to other PSI departments

🎯 Requirements

• Medical Doctor degree required • Minimum of 10 years' experience practicing Gastroenterology • Clinical Research experience preferred • Proficiency with MS Office applications • Communication, presentation and analytical skills • Problem-solving, team and detail-oriented

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume