Medical Monitor, Canada Board-Certified Psychiatrist

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

📋 Description

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

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

• Oversee the safety of trial participants.

• Engage in activities aimed at enhancing participant recruitment and retention.

• Deliver presentations on medical issues during kick-off and investigator meetings.

• Educate trial teams on therapeutic areas and the medical components of protocols.

• Create and evaluate trial-specific documents within the realm of medical monitoring.

• Manage ongoing risks associated with medical monitoring in trials.

• Conduct continuous medical reviews of operational clinical trial databases.

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

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

• Participate in trial-related committees, including IDMC and adjudication committees.

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

• Offer medical expertise as required.

• Prepare for and engage in trial audits and address audit findings.

• Take part in feasibility evaluations for potential and ongoing trials in Canada/region.

• Attend bid defense meetings and interactions with clients.

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

⛳️ Requirements

• A Medical Doctor degree is mandatory.

• Canada Board Certification in psychiatry is essential.

• At least 10 years of experience as a practicing psychiatrist is required.

• Clinical Research experience is preferred.

• Proficiency in MS Office applications is necessary.

• Strong communication, presentation, and analytical abilities are required.

• Must possess problem-solving skills, be team-oriented, and detail-focused.

• Must be based anywhere in Canada.

🏝️ Benefits

• Part-time/consultant position available.

• Option to work remotely from any location in Canada.

• Chance to join PSI's international network of medical professionals.

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

• Ability to utilize medical knowledge and expertise to assist in bringing new medications to patients.