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 • BrazilSeniorLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical trial management, focusing on patient safety and regulatory compliance. Proficient in medical monitoring, data analysis, and effective communication in both English and Portuguese.

Highest-signal resume keywords

Medical Doctor DegreeGastroenterology ExperienceClinical Research ExperienceProficiency in English and PortugueseMS Office Proficiency

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Medical MonitoringRegulatory Authority ResponsesTrial Risk ManagementSafety Report ReviewClinical Study Report ReviewData MonitoringProtocol Deviation ReviewPharmacovigilance SupportTrial-Specific Document DevelopmentParticipant Recruitment Support

Soft Skills

Communication SkillsPresentation SkillsAnalytical SkillsProblem-Solving SkillsTeam-Oriented

Industry Keywords

Clinical TrialsPatient SafetyIRB/IECTrial AuditsFeasibility AssessmentsBid Defense MeetingsTherapeutic ExpertiseOperational Clinical Trial DatabasesSafety QueriesTrial Participant Retention

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 point of 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 documents within medical monitoring scope
Manage ongoing trial risks related to medical monitoring
Perform ongoing medical review of operational clinical trial databases and support Medical Reviewers
Review protocol deviations, RAE reports, SAE narratives, safety reports, essential trial records, and annual IND reports
Support Pharmacovigilance with safety queries and interact with sponsors on site safety issues
Participate in independent data monitoring and adjudication committees
Support reconciliation of safety and operational clinical trial databases
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 audit 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

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 Portuguese
Proficiency with MS Office applications
Communication, presentation and analytical skills
Problem-solving, team and detail-oriented

Benefits

Comp & perks

Stability and innovation through PSI’s established CRO environment
Opportunity to build a career on the frontline of medical science
Opportunity to use medical expertise to help bring new medications to patients