Medical Monitor, Gastroenterologist

PSI CRO AG

. Provide medical input to global clinical studies and advise teams and business partners, focusing on patient safety and well-being .

Posted 11/6/2026full-timeRemote • ArgentinaSeniorLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical trial management, patient safety monitoring, and regulatory compliance, with a strong foundation in Gastroenterology and clinical research. Proficient in medical documentation, data review, and effective communication in both English and Spanish.

Highest-signal resume keywords

Medical Doctor DegreeGastroenterology ExperienceClinical Research ExperienceBilingual Proficiency in English and SpanishMS Office Proficiency

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Patient Safety MonitoringMedical ReviewRegulatory Authority ResponsesProtocol Deviation ReviewPharmacovigilance SupportClinical Trial Database ReviewTrial-Specific Document DevelopmentRisk ManagementData Management SupportParticipant Recruitment

Soft Skills

Communication SkillsPresentation SkillsAnalytical SkillsProblem-Solving SkillsTeam-Oriented

Industry Keywords

Clinical TrialsIRB/IECSAE NarrativesIND/SUSAR Safety ReportsMedical MonitoringFeasibility AssessmentsAudit FindingsTherapeutic ExpertiseData ReconciliationTrial-Related Committees

About the role

Key responsibilities & impact

Provide medical input to global clinical studies and advise teams and business partners, focusing on patient safety and well-being
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
Participate in 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
Manage ongoing trial risks related to medical monitoring
Conduct ongoing medical review of clinical trial databases and support Medical Reviewers
Review protocol deviations, RAE reports, SAE narratives, IND/SUSAR safety reports, and clinical study reports
Support Pharmacovigilance, Medical Data Review, and Data Management with safety and database reconciliation
Participate in trial-related committees, feasibility assessments, bid defense meetings, client interactions, audits, and follow-up on audit findings
Act as a medical expert and provide therapeutic expertise to other PSI departments

Requirements

What you’ll need

Medical Doctor degree required
Experience as a practicing Gastroenterologist (minimum of 10 years)
Clinical Research experience preferred
Full working proficiency in English and Spanish
Proficiency with MS Office applications
Communication, presentation and analytical skills
Problem-solving, team and detail-oriented