Medical Monitor (Gastroenterologist)

About the role

PSI is seeking an experienced Gastroenterologist to join its Medical Monitoring team as a Medical Monitor. Working remotely from Mexico, you will provide medical expertise for global clinical studies, ensuring patient safety and regulatory compliance.

Key responsibilities

• Act as the primary point of contact for all trial‑specific medical and safety questions.
• Provide input for regulatory and IRB/IEC responses on medical and safety matters.
• Monitor trial participant safety and support recruitment, retention, and boost activities.
• Present medical topics at kick‑off and investigator meetings and train trial teams on the therapeutic area.
• Develop and review trial‑specific documents related to medical monitoring.
• Manage ongoing trial risks and perform medical review of the operational clinical trial database.
• Review protocol deviations, RAE reports, SAE narratives, and support Pharmacovigilance with safety queries.
• Review IND/SUSAR safety reports, essential trial records, and annual IND reports as requested.
• Participate in IDMC or adjudication committees and support trial audits.
• Contribute to feasibility assessments, bid defenses, and client interactions.
• Provide therapeutic expertise to other PSI departments as a medical expert.

Required profile

• Medical Doctor degree.
• Minimum 10 years of practicing Gastroenterology.
• Clinical research experience preferred.
• Strong communication, presentation, analytical, problem‑solving, team‑oriented and detail‑focused abilities.

Required skills

• MS Office