Medical Monitor, Gastroenterologist

This is a fully remote position, open to applicants in Brazil.

📋 Description

• Contribute medical expertise to global clinical studies while advising teams and business partners, with an emphasis on patient safety and welfare.

• Serve as the main contact for trial-specific medical and safety inquiries.

• Provide input for responses to regulatory authorities and IRB/IEC.

• Oversee the safety of trial participants.

• Assist with activities related to participant recruitment and retention.

• Present medical topics during kick-off and investigator meetings.

• Train trial teams on the therapeutic area and the medical aspects of the protocol.

• Create and review trial-specific documents within the scope of medical monitoring.

• Manage ongoing trial risks associated with medical monitoring.

• Conduct continual medical review of operational clinical trial databases and support Medical Reviewers.

• Evaluate protocol deviations, RAE reports, SAE narratives, safety reports, essential trial records, and annual IND reports.

• Assist Pharmacovigilance with safety inquiries and engage with sponsors regarding site safety issues.

• Participate in independent data monitoring and adjudication committees.

• Aid in reconciling safety and operational clinical trial databases.

• Review clinical study reports, including safety narratives and TFLs.

• Offer medical expertise as required.

• Prepare for and engage in trial audits, following up on audit findings.

• Take part in feasibility assessments for trials within the country/region.

• Engage in bid defense meetings and client interactions.

• Function as a medical expert, providing therapeutic knowledge to other PSI departments.

⛳️ Requirements

• Medical Doctor degree is mandatory.

• A minimum of 10 years of experience as a practicing Gastroenterologist.

• Clinical Research experience is preferred.

• Full working proficiency in both English and Portuguese.

• Competence with MS Office applications.

• Strong communication, presentation, and analytical skills.

• Detail-oriented with problem-solving and teamwork capabilities.

🏝️ Benefits

• Stability and innovation provided by PSI’s well-established CRO environment.

• An opportunity to advance a career at the forefront of medical science.

• The chance to apply medical expertise in helping to bring new medications to patients.