Medical Monitor – Gastroenterologist

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

📋 Description

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

• Contribute to responses for regulatory bodies and IRBs/IECs.

• Oversee the safety of trial participants.

• Assist in activities aimed at recruiting and retaining participants.

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

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

• Create and review documents pertaining to trial-specific medical monitoring.

• Manage ongoing medical monitoring risks associated with trials.

• Conduct continuous medical evaluations of operational clinical trial databases.

• Assess protocol deviations, RAE reports, SAE narratives, IND/SUSAR safety reports, and annual IND reports.

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

• Engage in trial-related committees, such as IDMC and adjudication committees.

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

• Prepare for and take part in trial audits and address any findings.

• Involve in feasibility evaluations for potential and ongoing trials.

• Participate in bid defense meetings and client discussions.

• Offer therapeutic knowledge to other departments at PSI.

⛳️ Requirements

• A degree in Medicine is mandatory.

• At least 10 years of experience in the field of Gastroenterology.

• Experience in Clinical Research is desirable.

• Proficient in MS Office applications.

• Strong communication, presentation, and analytical abilities.

• Capable of problem-solving, with a focus on teamwork and attention to detail.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health and wellness benefits.

• Opportunities for professional development and continuing education.

• Flexible work arrangements and a supportive work environment.