Study Startup Specialist 2
About the job
- A college or university degree in Life Sciences, or an equivalent combination of education, training, and experience.
- At least 2 years of full-scope Study Startup experience in the country or region.
- Full working proficiency in English.
- Well-developed communication and organizational skills.
- Ability to negotiate and build relationships at all levels.
- Perform study startup activities and support all processes critical for site activation.
- Collect site documents for Institutional Review Board/Independent Ethics Committee submission and/or IP-RED process.
- File study-specific documentation in the Trial Master File in accordance with the Document Management Plan.
- Assist in feasibility research and site identification upon request.
- Facilitate site agreement and budget negotiations.
- Coordinate translation and review of study-specific documents.
- Identify and escalate project-specific issues as needed.
- Prepare and submit IP-RED packages.
- Ensure initial distribution of locally obtained clinical study supplies to sites and supervise initial distribution of investigational products and centrally obtained clinical study supplies to sites.
- Ensure exchange of information and documentation with investigational sites, off-site facilities, and vendors.
- Participate in developing site-specific startup timelines and enrollment projections and be responsible for meeting site activation targets under supervision.
About the company
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 cut site identification from six weeks to minutes by March 2026.
- Beijing office, opened April 28, 2026, puts PSI closer to Chinese regulators.
- Mexico, Toronto, and Japan expansions in 2025-2026 deepen coverage for Phase II-III trials.
What critics are saying
- Parexel, IQVIA, and Medpace outspend PSI on technology, sales, and global program depth.
- SYNETIC's AI promises face validation risk if recommendations miss enrolling sites in 2026.
- One sponsor-program failure can dent PSI's repeat-business flywheel and pressure 2027 growth.
What makes PSI CRO unique
- PSI CRO remains privately owned, independent, and reached 93% repeat business in 2025.
- PSI CRO delivered 15% revenue growth in 2024 while keeping 9% global turnover.
- PSI's 56-country footprint plus Beijing, Toronto, Mexico, and Japan offices shortens sponsor-to-site decisions.
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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
PSI CRO to present agile models for emerging biotech at OCT New England. Ninety-three percent repeat business and 15% revenue growth in a single year puts PSI CRO in an unusual position for a mid-size CRO: sponsors keep coming back, which suggests the agility argument it plans to make at OCT New England next week is grounded in something operational rather than just a conference pitch. On October 27 at Encore Boston Harbor in Boston, Benjamin Raccanova, PSI's Head of Business Oversight, joins Stream C of the 18th Annual Outsourcing in Clinical Trials New England conference for a peer-driven session on how small and emerging biotech sponsors can hold onto operational control while scaling global programs. The pressure point is real: investor timelines, regulatory scrutiny, and the site-level complexity introduced by the FDA's 2024 final guidance on decentralized clinical trials all pull in different directions for a sponsor that doesn't have a 500-person clinical operations team to absorb the friction. The debate framing matters here. Raccanova's panel asks directly whether large CRO operating models are equipped to serve emerging biotech, which sets up a structural question that PSI has a commercial interest in answering a particular way, but also has data to back up. In 2024, 93% of PSI's studies enrolled on time or ahead of schedule. For a biotech sponsor burning cash against a runway, a slip in enrollment doesn't just delay a readout, it often triggers a bridge financing conversation. The session runs at 3:15 PM on October 27. Whether the peer discussion produces anything transferable beyond the room will depend on how many attending sponsors are willing to describe what broke in their last CRO relationship out loud. That candor, not the panel format itself, is what tends to make these conversations useful.
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.