Medical Monitor, Canada Board-Certified Psychiatrist

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PSI CRO AG

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1996

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

PSI CRO AG is a global contract research organization (CRO) that specializes in conducting clinical trials. The company focuses on delivering pivotal Phase 2 and 3 clinical trials across various therapeutic areas, including Inflammatory Bowel Diseases, Oncology, Hematology, Infectious Diseases, Multiple Sclerosis, and Rare Diseases. PSI utilizes a proprietary technology platform for clinical trial planning and financial tracking to ensure trials are conducted on time and within budget. The company is recognized for its expertise, quality, compatibility, and reliability, having been awarded the CRO Leadership Awards for multiple consecutive years.

📋 Description

• Acts as the primary point of contact for all parties on all trial-specific medical and safety-related questions • Provides input for responses to regulatory authorities and Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs) on trial-specific medical and safety-related questions • Monitors trial participant safety • Participates in trial participant recruitment boost and retention activities • Presents on medical matters at kick-off and investigator meetings • Trains trial team in the therapeutic area and medical aspects of the protocol • Develops and reviews trial-specific documents within the scope of medical monitoring • Manages ongoing trial risks related to medical monitoring • Performs ongoing medical review of the operational clinical trial database; provides support to Medical Reviewer(s) assigned to the trial • Reviews protocol deviations • Reviews RAE reports, writes and/or reviews SAE narratives, supports Pharmacovigilance team with outstanding safety queries, interacts with sponsor on site safety issues • Reviews IND/SUSAR Safety Reports, updates/amendments to essential trial records, and annual IND reports with sponsor data (per sponsor request) • Participates in management of trial-related committees (e.g., independent data monitoring committee (IDMC)/adjudication committees) as described in the corresponding trial-specific charter(s) • Supports Pharmacovigilance, Medical Data Review and Data Management with reconciliation of safety and operational clinical trial databases • Reviews clinical study reports (CSRs), including safety narratives and tables, figures, and listings (TFLs) • Provides medical expertise on an as-needed basis in trials where medical monitoring is not a contract deliverable • Prepares for and participates in trial audits, follows up on audit findings • Participates in feasibility assessment of potential and ongoing trials in the country/region • Participates in bid defense meetings and other interactions with clients • Acts as a medical expert and provides therapeutic expertise to other PSI departments

🎯 Requirements

• Medical Doctor degree required • Canada Board Certification in psychiatry required • Experience as a practicing psychiatrist (minimum of 10 years) • Clinical Research experience preferred • Proficiency with MS Office applications