Full-Time
Medical Monitoring
Gastroenterology
PSI CRO
1,001-5,000 employees
Global CRO delivering on-time patient enrollment
No salary listed
Sydney NSW, Australia
Remote
MD
 Biology & Biotech (1) |
|---|
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- Medical Doctor degree
- Prior experience in Clinical Research
- Ability to interact with and train clinical monitors and physician investigators, and build constructive, trusting and respectful relationships with colleagues at all levels within and outside the organization
- Proficiency with MS Office applications
- Must possess excellent leadership, communication, presentation, and organizational skills and be able to exercise sound critical thinking and problem-solving skills and execute position responsibilities with minimal guidance
- Advise clients, project teams, sites, data safety monitoring boards, regulatory agencies and third-party vendors on medical matters
- Collaborate with internal departments in the preparation of clinical development plans, protocols, investigator brochures, annual reports, clinical study reports, manuscripts, and different scientific presentations
- Review and analysis of clinical data to ensure the safety of study participants in clinical studies
- Ensure that the reported data is accurate, complete, and verifiable, and that the conduct of the trial is in compliance with the currently approved protocol/amendments
- Address safety issues across the study from sites and the study team
- Participate in bid defense meetings
- Assist in Pharmacovigilance activities
- Identify Program risks, and create and implement mitigation strategies with Clinical Operations
- Ability to organise and lead clinical development advisory boards and safety monitoring boards
- Ensure Study team compliance with local regulatory agencies, ICH and GCP guidelines
- Review and sign off clinical documents with respect to medical relevance
- Board-certification in Gastroenterology is preferred
- Clinical experience in major therapeutic area (Oncology, Infectious disease, Gastroenterology, Hematology, Internal Medicine) is desirable
- Familiar and comfortable with clinical concepts, practices and local regulations regarding clinical research trials experience with local health authority interactions leading to drug approval strongly 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
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Simplify's Take
What believers are saying
- SYNETIC cuts site identification from six weeks to minutes, speeding sponsor startup decisions.
- Mississauga office and Canada leadership expansion strengthen North American execution on pivotal phase II/III studies.
- Japan, China, and Toronto expansions deepen local access while preserving PSI’s global operating model.
What critics are saying
- SYNETIC depends on clean historical data; bad inputs poison site recommendations immediately.
- China expansion raises exposure to regulators, data localization, and cross-border trial approvals in 2026.
- PSI’s consultant-heavy CRO model faces attrition and margin pressure if recruitment quality slips.
What makes PSI CRO unique
- SYNETIC launched January 29, 2026, combining site history across 62 countries and 3 million sites.
- PSI opened Beijing April 28, 2026, positioning operations near Chinese regulators and institutions.
- PSI hired heavily in 2026, with 254 open roles and 73 posted last month.
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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.