Medical Monitor – Gastroenterologist

PSI CRO AG

. Act as the primary point of contact for trial-specific medical and safety-related questions .

Posted 11/6/2026full-timeRemote • MexicoSeniorLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Gastroenterology and clinical trial management, with a strong focus on participant safety, regulatory compliance, and effective communication. Proficient in developing medical monitoring documents and conducting thorough reviews of clinical data.

Highest-signal resume keywords

Medical Doctor Degree10 Years Gastroenterology ExperienceClinical Research ExperienceMS Office ProficiencyCommunication And Presentation Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Medical MonitoringRegulatory Authority InteractionProtocol Deviation ReviewSafety Report ReviewData Management SupportTrial Risk ManagementMedical Data ReviewTrial Audit PreparationFeasibility AssessmentParticipant Recruitment Support

Soft Skills

Analytical SkillsProblem-SolvingTeam-OrientedDetail-Oriented

Industry Keywords

PharmacovigilanceClinical TrialIRBIECIDMCAdjudication CommitteesSafety Database ReconciliationClinical Study ReportsSAE NarrativesIND Reports

About the role

Key responsibilities & impact

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

What you’ll need

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