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Clinical Operations Lead

PSI CRO Japan株式会社

  • 課長以上
  • 外資系企業

想定年収

800万円 ~ 970万円

勤務地

大阪府 東京都

従業員数

30名(2026年2月)

仕事内容

In this role, you will build focus on line management and mentoring of Monitors on project-specific activities.
Hybrid workstyle at either Tokyo or Osaka office.


The scope of responsibilities will include:

・Prepare, conduct and report site selection, initiation, routine monitoring and closeout visits.
・Act as a Mentor for the Monitors on project-specific activities and supporting their professional development.
・Plan and conduct supervised monitoring visits with training, authorization, and ongoing assessment purposes.
・Build and maintain good relationships with sites’ staff involved in the study conduct.
・Contribute to the performance appraisal of monitors.
・Training, coaching and mentoring the Clinical Operations team.
・Supervise activities of Site Management Associates related to the flow of documents and laboratory supplies between the site and the Central/Regional Laboratory/Central Reviewer.
・Development and implementation of quality control, ensuring data integrity and compliance at a site level.
・Ensure proper handling, accountability and reconciliation of all Investigational Products and clinical study supplies.
・Supports Clinical Operations Managers with resource allocation and utilization of departmental staff
・Performs additional Clinical Operations supervisory tasks at the discretion oftheir Line Manager

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

1人

応募条件

技能/経験

Qualifications

・College/University degree in Life Sciences or an equivalent combination of education, training & experience.
・Minimum 2 years of CRA mentoring or training experience.
・Full working proficiency in Japanese and English.
・Ability to successfully mentor and train Clinical Operations staff.
・Proficiency in MS Office applications.
・Availability to travel (up to 60%).
・Ability to plan and work in a dynamic team environment.
・Communication, collaboration, and problem-solving skills.

学歴

大学

職務経験

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(3か月)

給与

年俸制

年収:800万円 ~ 970万円

月収:67万円~81万円

月額基本給:67万円~81万円

賞与・インセンティブ

昇給

有り 年1回

勤務地

大阪府 東京都

東京:東京都千代田区丸の内2-7-2 JPタワー14階
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

フレックスタイム制

残業手当

通常の残業代

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:3回

求人No.:NJB2410732

最終更新日:2026/9/15

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

〒100-7014 東京都千代田区丸の内2-7-2 JPタワー14階

株式公開

日系・外資

外資

事業内容

PSI is a leading Contract Research Organization (CRO) with over 30 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.:NJB2410732

最終更新日:2026/9/15

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  3. PSI CRO Japan株式会社:Clinical Operations Leadの求人情報詳細