Medical Monitor, Canada Board-Certified Psychiatrist

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

📋 Description

• Serves as the main point of contact for all stakeholders concerning trial-specific medical and safety-related inquiries.

• Contributes to the preparation of responses for regulatory bodies and Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs) regarding trial-specific medical and safety-related matters.

• Oversees the safety of trial participants.

• Engages in activities aimed at enhancing trial participant recruitment and retention.

• Delivers presentations on medical topics during kick-off and investigator meetings.

• Educates the trial team on the therapeutic area and medical considerations outlined in the protocol.

• Creates and reviews trial-specific documents pertaining to medical monitoring.

• Manages the ongoing medical monitoring-related risks associated with the trial.

• Conducts continuous medical reviews of the operational clinical trial database and provides assistance to the Medical Reviewer(s) assigned to the trial.

• Evaluates protocol deviations.

• Assesses RAE reports, drafts and/or reviews SAE narratives, assists the Pharmacovigilance team with outstanding safety inquiries, and collaborates with the sponsor on site safety matters.

• Reviews IND/SUSAR Safety Reports, updates/amendments to essential trial documentation, and annual IND reports incorporating sponsor data (as per sponsor request).

• Engages in the management of trial-related committees (e.g., independent data monitoring committee (IDMC)/adjudication committees) as outlined in the relevant trial-specific charter(s).

• Aids Pharmacovigilance, Medical Data Review, and Data Management with the reconciliation of safety and operational clinical trial databases.

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

• Offers medical expertise as needed in trials where medical monitoring is not a contractual obligation.

• Prepares for and participates in trial audits, addressing any audit findings.

• Involved in feasibility assessments for potential and ongoing trials within the country/region.

• Participates in bid defense meetings and other client interactions.

• Acts as a medical expert and provides therapeutic knowledge to other departments within PSI.

⛳️ Requirements

• A Medical Doctor degree is required.

• Canada Board Certification in psychiatry is mandatory.

• A minimum of 10 years of experience as a practicing psychiatrist is essential.

• Clinical Research experience is preferred.

• Proficient in MS Office applications.

🏝️ Benefits

• Competitive salary and performance-based incentives.

• Opportunities for professional development and continuing education.

• Comprehensive health and wellness benefits.

• Supportive and collaborative work environment.