Medical Monitor, Gastroenterologist

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

📋 Description

• Serve as the main point of contact for medical and safety-related inquiries specific to the trial.

• Contribute to the preparation of responses for regulatory bodies and Institutional Review Boards/Independent Ethics Committees.

• Oversee the safety of trial participants.

• Engage in activities aimed at recruiting and retaining participants.

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

• Educate trial teams on the therapeutic domain and medical aspects of the protocol.

• Create and review medical monitoring documents tailored for the trial.

• Manage ongoing medical monitoring risks associated with the trial.

• Conduct continuous medical reviews of operational clinical trial databases.

• Examine protocol deviations, RAE reports, SAE narratives, safety documentation, trial records, and annual IND reports.

• Assist Pharmacovigilance, Medical Data Review, and Data Management with database reconciliation and safety-related inquiries.

• Take part in trial-related committees, including independent data monitoring and adjudication committees.

• Review clinical study reports, encompassing safety narratives and related tables, figures, and listings.

• Prepare for and engage in trial audits and address audit findings.

• Assist in feasibility evaluations of potential and ongoing trials within the country/region.

• Participate in bid defense meetings and collaborate with clients.

• Function as a medical authority, providing therapeutic insights to other PSI departments.

⛳️ Requirements

• A Medical Doctor degree is mandatory.

• At least 10 years of experience as a practicing Gastroenterologist is required.

• Clinical Research experience is a plus.

• Full working proficiency in both English and Portuguese.

• Familiarity with MS Office applications is necessary.

• Strong communication, presentation, and analytical abilities.

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

🏝️ Benefits

• Flexible remote work / home-based role in Brazil.

• Collaborate with an international team of medical professionals.

• Opportunities for career development at the forefront of medical science.

• Chance to apply medical expertise in the advancement of new treatments for patients.