Study Startup Specialist(大阪)
想定年収
500万円 ~ 800万円
勤務地
大阪府
従業員数
30名(2026年2月)
仕事内容
Take your career to the next level and lead challenging study activation process on a country/regional level. You will support clinical research teams and ensure PSI projects start smoothly and on time.
You will:
Maintains study-specific and corporate startup tracking systems
Facilitates site budgets and contract negotiations
Supports site regulatory document collection
Under supervision, may prepare initial submission dossiers to competent authorities, ethics committees, and/or site submission dossiers (as applicable)
Communicates with the project team and investigational sites throughout the study startup phase
Develops site specific startup timelines and enrollment projections and is responsible for meeting the site activation milestones
May review study specific translations
Supervises Trial Master File (TMF) maintenance throughout the study startup phase
仕事内容変更範囲
会社の指示する業務
職位
ー
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
ー
応募条件
技能/経験
College/University degree in Life Sciences or an equivalent combination of education, training and experience
2-3 years prior clinical study and site startup experience
Well-developed communication and organizational skills
Ability to negotiate and build relationships at all levels
Leadership, mentoring, and organizational skills
English and Japanese skills (High Business level to Fluent)
学歴
大学
職務経験
要 (2年以上)
業界経験
ー
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
ー
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:500万円 ~ 800万円
月収:42万円~67万円
月額基本給:42万円~67万円
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
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
コアタイム 11:00 ~ 14:00
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
ー
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.:NJB2350972
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
ー
その他の特色
ー
売上実績
求人No.:NJB2350972
最終更新日:2026/1/26

