Medical Monitor, Gastroenterologist

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

📋 Description

• Offer medical guidance for global clinical studies while advising teams and business partners with a focus on patient safety and well-being.

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

• Contribute to responses for regulatory authorities and IRB/IEC.

• Oversee the safety of trial participants.

• Engage in activities related to participant recruitment and retention.

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

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

• Create and review trial-specific documentation.

• Manage ongoing medical monitoring risks associated with the trial.

• Conduct continuous medical reviews of clinical trial databases and assist Medical Reviewers.

• Evaluate protocol deviations, RAE reports, SAE narratives, IND/SUSAR safety reports, and clinical study reports.

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

• Take part in trial-related committees, feasibility assessments, bid defense meetings, client interactions, audits, and address audit findings.

• Act as a medical expert, providing therapeutic insight to other departments within PSI.

⛳️ Requirements

• A Medical Doctor degree is required.

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

• Clinical Research experience is preferred.

• Full working proficiency in both English and Spanish.

• Proficient in MS Office applications.

• Strong communication, presentation, and analytical skills are essential.

• Must be detail-oriented with excellent problem-solving and teamwork abilities.

🏝️ Benefits

• Comprehensive health insurance and wellness programs.

• Opportunities for professional development and continuing education.

• Flexible work arrangements to promote work-life balance.

• Supportive and collaborative work environment.