Medical Monitor – Canada Board-Certified Gastroenterologist

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

📋 Description

• Serve as the main medical and safety liaison for all stakeholders regarding trial-specific inquiries.

• Contribute to regulatory bodies and Institutional Review Boards/Independent Ethics Committees.

• 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 assess trial-specific medical-monitoring documentation.

• Manage ongoing risks associated with medical monitoring.

• Conduct continuous medical evaluations of operational clinical trial databases.

• Review protocol deviations, RAE reports, SAE narratives, IND/SUSAR safety reports, and yearly IND reports.

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

• Take part in Independent Data Monitoring Committees and adjudication panels.

• Evaluate clinical study reports, including safety narratives and tables, figures, and listings (TFLs).

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

• Involve in feasibility assessments, bid defense meetings, and interactions with clients.

• Function as a medical specialist, providing therapeutic knowledge to PSI departments.

⛳️ Requirements

• A Medical Doctor degree is mandatory.

• Canada Board Certification in Gastroenterology is required.

• At least 10 years of experience as a practicing Gastroenterologist is necessary.

• Clinical Research experience is advantageous.

• Proficiency in MS Office applications is essential.

• Strong communication, presentation, and analytical abilities.

• Capable of problem-solving, working collaboratively in teams, and paying attention to detail.

• Willingness and capability to provide medical expertise for global clinical studies and associated trial activities.

🏝️ Benefits

• Remote work / home-based opportunities available in Canada.

• Full-time employment status.

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

• Career advancement at the forefront of medical science.

• Opportunity to leverage medical expertise in aiding the development of new medications for patients.