Full-Time
Medical Monitor
Canada Board-Certified Gastroenterologist
PSI CRO
1,001-5,000 employees
Global CRO delivering on-time patient enrollment
No salary listed
Remote in Canada
Remote
MD
 Biology & Biotech (1) |
|---|
Get referred to PSI CRO
See people who can refer or advise you
- A Medical Doctor degree is required.
- Canada Board Certification in Gastroenterology is required.
- A minimum of 10 years of experience practicing gastroenterology is required.
- Proficiency with Microsoft Office applications is required.
- Communication, presentation, analytical, problem-solving, teamwork, and attention-to-detail skills are required.
- Act as the primary point of contact for trial-specific medical and safety-related questions.
- Provide input for responses to regulatory authorities and Institutional Review Boards or Independent Ethics Committees.
- Monitor trial participant safety.
- Participate in participant recruitment and retention activities.
- Present medical matters at kick-off and investigator meetings.
- Train trial teams in the therapeutic area and medical aspects of the protocol.
- Develop and review trial-specific documents within the scope of medical monitoring.
- Manage ongoing trial risks related to medical monitoring.
- Perform ongoing medical review of operational clinical trial databases and support assigned Medical Reviewers.
- Review protocol deviations, RAE reports, serious adverse event narratives, safety reports, essential trial records, annual IND reports, clinical study reports, and safety tables, figures, and listings.
- Support Pharmacovigilance, Medical Data Review, and Data Management with reconciliation of safety and operational clinical trial databases.
- Participate in trial-related independent data monitoring and adjudication committees.
- Provide medical expertise and therapeutic expertise to PSI departments and trials where medical monitoring is not a contract deliverable.
- Prepare for and participate in trial audits and follow up on audit findings.
- Participate in feasibility assessments of potential and ongoing trials in the country or region.
- Participate in bid defense meetings and client interactions.
- Clinical research experience is preferred.
PSI CRO is a global contract research organization that handles clinical trials for multiple therapeutic areas, with a focus on enrolling patients on schedule and delivering studies on time. Its services span feasibility assessments, trial planning, site selection, patient recruitment, and multi-continent trial execution across 50+ countries, backed by medical doctor resources dedicated to accurate timeline predictions. Unlike many CROs, PSI emphasizes predictable enrollment and on-time project delivery, aiming for high client satisfaction and repeat business through a pragmatic, no-nonsense approach. The company’s goal is to be regarded as the best CRO in the world by both clients and employees, achieved through reliable timelines, strong execution, and low staff turnover.
Company Size
1,001-5,000
Company Stage
N/A
Total Funding
N/A
Headquarters
Switzerland
Founded
1995
Get referred to PSI CRO
See people who can refer or advise you
Simplify's Take
What believers are saying
- Toronto expansion in January 2026 deepens PSI's North American delivery capacity.
- Beijing's April 2026 launch improves access to Chinese regulators and investigator networks.
- SYNETIC reduces non-enrolling site waste, saving studies millions in recruitment costs.
What critics are saying
- IQVIA, ICON, and Parexel can copy PSI's AI site-selection advantage quickly.
- Beijing and Toronto offices raise fixed costs if sponsor demand softens in 2026.
- A major sponsor loss would crush utilization and threaten PSI's global CRO model.
What makes PSI CRO unique
- PSI CRO opened Beijing in April 2026 to stay close to Chinese regulators.
- PSI CRO operates a 58-country platform with 3,200-plus employees worldwide.
- SYNETIC cuts site identification from six weeks to minutes with explainable AI.
Help us improve and share your feedback! Did you find this helpful?
Benefits
Health Insurance
Paid Vacation
Flexible Work Hours
Hybrid Work Options
Remote Work Options
Wellness Program
Mental Health Support
Conference Attendance Budget
Professional Development Budget
Company News
From Shanghai to Beijing: PSI CRO expands its footprint in China with a new Beijing office. Beijing, China - April 28, 2026 - PSI CRO, a Swiss-based global full-service contract research organization, today announced the opening of its second office in China, located in China World Tower B in Beijing's Chaoyang District. In 2019, PSI established its first China office in Shanghai, where the local team has steadily grown while supporting sponsors across the region. By adding a Beijing location, PSI brings its team closer to key drug regulatory authorities and leading research institutions. China is playing an increasingly important role in global clinical development, creating a growing need for strong local operational and regulatory support. PSI's presence in Beijing helps meet that need, combining local expertise with coordinated global teams to support clear decision-making and predictable, on-time delivery for sponsors. For PSI, the Beijing office represents a targeted investment to support clients where it matters most - close to regulators, close to investigator sites, and close to strategic partners.
PSI CRO, a global clinical research organisation, has reduced clinical trial site identification from up to six weeks to minutes using SYNETIC, an AI knowledge engine powered by the Arango Contextual Data Platform. The system helps identify higher-performing trial sites and minimise costly non-enrolling institutions, which account for 30-40% of trial sites. Clinical trials can cost over $160 per minute operationally, and activating a trial site costs $30,000 or more. With 15% of sites never enrolling a single patient, failed recruitment can cost millions per study. SYNETIC unifies fragmented clinical research data into a single contextual layer, preserving relationships across investigators, institutions, protocols and historical outcomes. The platform provides explainable AI recommendations, including rationale, supporting evidence and confidence levels, enabling data-driven site selection in minutes rather than weeks.
PSI CRO strengthens Canadian presence with new Toronto office and leadership role. PSI CRO has broadened its footprint in Canada by opening a new office in the Toronto area and naming an experienced industry leader to guide its operations there. The office, located in Mississauga, Ontario, builds on the company's established Canadian presence and commitment to clinical research excellence. PSI CRO has been active in Canada for over a decade, supporting complex clinical trials with a focus on dependable delivery and strong relationships with research sites. As part of this expansion, David Allen, MBA, has been appointed as Country Manager for Canada. Allen brings more than 30 years of experience in clinical research from both sponsor and CRO environments. In his new role, he will lead efforts to enhance the company's operational capabilities in the local market and ensure alignment with PSI's global standards for on-time trial execution. PSI's continued growth in North America reflects broader trends of increasing trial activity in the region, particularly for pivotal phase II and phase III studies where precision and efficiency are critical. The expanded Toronto operations aim to further support sponsors with rigorous trial planning and execution.
TOKYO, 14 March 2025 - PSI CRO AG, a global Swiss-based clinical research organization (CRO), is pleased to announce the appointment of Sayaka Kaji as Country Manager for Japan.
Psi CRO Ag launched a CRA Academy to provide to help its team members develop therapeutic expertise as well as soft skills to manage key relationships with sites.