Medical Monitor, Gastroenterologist

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

📋 Description

• Serve as the main point of contact for inquiries related to medical and safety aspects of 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 boosting participant recruitment and retention.

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

• Educate trial teams on the therapeutic area and medical elements of the protocol.

• Create and evaluate trial-specific documentation within the realm of medical monitoring.

• Address ongoing trial risks associated with medical monitoring.

• Conduct continuous medical reviews of operational clinical trial databases.

• Analyze protocol deviations, RAE reports, SAE narratives, safety queries, and IND/SUSAR Safety Reports.

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

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

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

• Offer medical expertise as required.

• Prepare for and engage in trial audits, addressing audit findings as needed.

• Participate in feasibility assessments for both potential and ongoing trials within the country/region.

• Join bid defense meetings and interact with clients.

• Act as a medical expert, providing therapeutic knowledge to various PSI departments.

⛳️ Requirements

• A Medical Doctor degree is mandatory.

• Minimum of 10 years of experience as a practicing Gastroenterologist.

• Clinical Research experience is preferred.

• Full working proficiency in both English and Spanish.

• Competence in MS Office applications.

• Strong communication, presentation, and analytical abilities.

• Detail-oriented with problem-solving and team collaboration skills.

• Capability to work from home in Argentina.

🏝️ Benefits

• Employees have the option to work remotely.

• Full-time employment opportunities available.

• Chance to be part of an international team of medical professionals.

• Career growth at the forefront of medical science.

• Opportunity to leverage medical expertise to assist in bringing new medications to patients.