Medical Monitor, Gastroenterologist

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

📋 Description

• Deliver medical insights for global clinical studies while advising teams and business partners.

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

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

• Oversee the safety of trial participants.

• Assist 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 evaluate trial-specific medical monitoring documents.

• Manage medical monitoring-related trial risks.

• Conduct ongoing medical reviews of clinical trial databases.

• Assess protocol deviations and safety reports; draft or review SAE narratives.

• Collaborate with Pharmacovigilance on safety queries and site safety matters.

• Analyze IND/SUSAR safety reports and annual IND submissions.

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

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

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

• Provide medical expertise as needed.

• Prepare for and engage in trial audits, ensuring follow-up on findings.

• Participate in feasibility assessments for trials within the region.

• Attend bid defense meetings and interact with clients.

• Act as a medical expert, offering therapeutic knowledge to other PSI departments.

⛳️ Requirements

• A Medical Doctor degree is required.

• At least 10 years of experience in practicing Gastroenterology.

• Clinical Research experience is preferred.

• Proficiency in MS Office applications is necessary.

• Strong communication, presentation, and analytical skills.

• Capable of problem-solving, teamwork, and attention to detail.

🏝️ Benefits

• Remote work opportunity in a home-based position within Mexico.

• Chance to join PSI’s international Medical Monitoring team.

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

• Ability to contribute expertise toward the introduction of new medications for patients.