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Regional Project Lead【関西】

PSI CRO Japan株式会社

想定年収

800万円 ~ 1,200万円

勤務地

大阪府

従業員数

30名(2026年2月)

仕事内容

Responsibilities:
In this role you will streamline activities of project teams in Japan and ensure consistency of Clinical Operations processes across regions.
You will ensure meeting study milestones by project teams on a country level, report study progress to clients and global stakeholders.

The scope of responsibilities will include:
▪ Coordinate project team work in Japan
▪ Act as project management contact for the project team and PSI support services
▪ Act as a contract for global clients, contractors, subcontractors and third-party vendors
▪ Perform study status review and progress reporting, collect and report project status updates
▪ Develop and update project planning documents, essential study documents and project manuals/instructions
▪ Supervise clinical project team performance, manage, and report on Key Performance Indicators (KPIs) inJapan
▪ Ensure that the project timelines and subject enrollment targets are met
▪ Coordinate maintenance of study-specific and corporate tracking systems
▪ Oversee site selection and startup, site contractual and budget negotiations
▪ Supervise project team and site training, perform field training of monitors tailored to the project needs
▪ Ensure team compliance with project-specific training matrix
▪ Supervise preparation, conduct and reporting of site selection, site initiation, routine monitoring and closeout visits
▪ Review site visit reports and ensures monitoring and reporting standards are met
▪ Oversee investigator and site payments
▪ Supervise

仕事内容変更範囲

会社の指示する業務

職位

募集背景

日本法人立ち上げに伴う増員での募集

募集人数

2人

応募条件

技能/経験

▪ MPharm, RN or university/college degree in Life Sciences or an equivalent combination of education,training and experience
▪ Minimum 4 years’ site monitoring experience in Japan
▪ At least 2 years’ experience as Lead Monitor
▪ Experience supervising clinical project activities and leading clinical project teams
▪ Experience in oncology, gastroenterology, infectious diseases, autoimmune diseases, or any rare disease indication is preferable
▪ Communication, presentation, and customer-service skills
▪ Team building, leadership and organizational skills
▪ Full working proficiency in English
▪ Proficiency in MS Office applications, including MS Project

学歴

大学

職務経験

(4年以上)

業界経験

年齢

年齢制限不問  

英語力

中級以上

その他語学力

語学力詳細

勤務条件

雇用形態

無期雇用

試用期間

有り(6か月)

給与

年俸制

年収:800万円 ~ 1,200万円

月収:67万円~100万円

月額基本給:67万円~100万円

賞与・インセンティブ

昇給

有り 年1回

勤務地

大阪府

東京:千代田区丸の内二丁目6 番1 号丸の内パークビルディング8 階xLINK 丸の内(区画No. 15 )
大阪:大阪市北区梅田2-2-2 ヒルトンプラザウエストオフィスタワー18階

交通手段1 沿線名:各線 駅名:東京 最寄駅から:徒歩1分

交通手段2 沿線名:各線 駅名:大阪 最寄駅から:徒歩3分

勤務地変更範囲

会社の定める事業所

出向

就業時間

09:00~18:00

休憩時間:60分

残業:月5時間~20時間程度

管理監督職

残業手当

管理監督職のため、労働基準法41条により、労働時間、休憩、休日の割増賃金の規定は適用されません。

通勤手当

交通費:全額支給

その他手当

休日・休暇

完全週休二日制, 土, 日, 祝日, 年末年始

年間休日:125

年間有給休暇:入社7ヶ月目には最低10日以上

社会保険

雇用保険, 健康保険, 労災保険, 厚生年金

福利厚生

各種社会保険完備

受動喫煙対策

就業場所 全面禁煙

備考

選考内容

選考プロセス

適性試験:無し 面接回数:2回

求人No.:NJB2349121

最終更新日:2026/1/26

企業情報

企業名

PSI CRO Japan株式会社

代表者名

代表取締役 Nick Sinackevich (シナケヴィッチ・ニック) PSI Japan Country Manager: Sayaka Kaji (梶さやか)

設立

2024年9月

従業員数

30名(2026年2月)

資本金

10,000,000円

本社所在地

〒103-0025 東京都千代田区丸の内二丁目6番1号 丸の内パークビルディング8階xLINK丸の内(区画No.15)

株式公開

日系・外資

外資

事業内容

PSI is a leading Contract Research Organization (CRO) with over 25 years of experience in the pharmaceutical industry. Originating from Switzerland, PSI is a privately owned, full-service CRO with a global reach, supporting clinical trials across multiple countries and continents. Our reputation for being highly selective about the projects we undertake highlights our commitment to delivering high-quality, timely services across a broad spectrum of therapeutic indications.

In an industry where cost-cutting and layoffs are common, PSI stands out as a stable and secure workplace. Our dedication to stability is evident in our exceptionally high repeat and referral business rate and minimal staff turnover. Many of our colleagues have been with us for over 15 years, contributing to our long-standing traditions and history. Our expansion into Japan continues this legacy, and we seek team members who will grow with us for the long term.
At PSI, we foster an environment where a diverse range of colleagues feel welcomed and valued. Our inclusive culture is a cornerstone of our success, enabling us to attract and retain top talent globally.

We are not just about conducting clinical trials; we are about building a community where every team member has the opportunity to thrive and contribute to groundbreaking advancements in the pharmaceutical industry.

事業に関する特色

■Mission
Our mission is to be the best CRO in the world as measured by our employees, clients, sites, and vendors.

Employees come first because being in the people business, we know only happy employees can make happy clients, sites, and vendors. In fact, we do not like the word “employees” and hardly ever use it. We prefer to say “teammates”.

We work in teams, and that shapes our collective mindset. Connection and interdependence are important to us and we devote time, attention, and funds to bring teams together. Many newcomers quickly comment on the uncommon team atmosphere they perceive here from day one.

■Management
PSI is privately owned by a group of managers who set it up a quarter of a century ago and still come to work every day.

These folks succeeded in keeping the company fully independent. In our industry, this is unique and gives us great advantage and freedom.

The power distance within PSI is very short. It is routine for our upper level officers to be involved in all sorts of dialogue with teammates of all levels. We make a point to be approachable, receptive to new ideas, and open to feedback. After all, we want to identify our weaknesses before the market does.

Both our country and functional management have a fair degree of autonomy in making decisions and creating an engaging working environment. They have operational freedom to make nuanced country-and department-specific adjustments while nurturing the global PSI culture that unites us across six continents.


■The PSI Advantage
PSI CRO has received 2024 CRO Leadership Awards in the categories of Expertise, Quality, Compatibility, and Reliability in the Overall (combined Big and Small Pharma) respondent group. This is the seventh consecutive year that PSI has received leadership awards presented by Clinical Leader and Life Science Connect based on research conducted by ISR. The awards recognize CROs that are voted by sponsors to meet or exceed expectations.

会社の特色

その他の特色

売上実績

求人No.:NJB2349121

最終更新日:2026/1/26

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