At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

＜臨床開発部について＞

臨床開発部は、日本国内外の臨床試験（治験）を通じて新しい医療機器の有効性と安全性を評価・検証し、厚生労働省（医薬品医療機器総合機構）へ承認申請を行い医療機器として製造販売承認を取得する業務を担います。そして製造販売承認を取得した新医療機器等に対しては、日常の診療において機器を使用したときの医療機器の品質、有効性及び安全性等に関する情報の収集、検出、確認又は検証のために行う調査又は試験を実施し、臨床試験（治験）では得られなかった医療機器の適正な使用についての情報、安全性情報などを集める業務も担います。また、市販後臨床研究などを通じて、Medtronic製品の更なる臨床的な有用性を探るためのエビデンス構築を担います。

Medtronicの臨床開発部は、「Clinical Research部門」、「Clinical Solutions部門」、「Evidence Solutions部門」の3つの組織で構成されています。Clinical Research部門ではすべての製造販売前のプロジェクトを担当し、Clinical Solutions部門はモニタリング活動および安全性報告活動を担当し、Evidence Solutions部門は市販後プロジェクトを担当しています。

臨床研究部門は3つの部門で構成されており、第1部門はCRM/CAS、第2部門はSH/CRDN/PVH、第3部門はMS/NS関連のすべての医療機器を担当し、プロジェクトの中核として、国内外の関連部署や部門との連携・協力を担っています。

＜業務の概要＞

臨床試験や海外データ申請など、さまざまな種類の臨床研究を実施するために臨床チームを統括・指揮する責任を負います。また、事業環境や規制要件を考慮して担当する臨床研究の戦略を策定し、国内・海外の研究チームや薬事部門などの社内チームメンバーだけでなく、サプライヤー、政府機関、医療従事者、医師などの社外関係者とも連携を図ります。

＜業務内容＞

1.　試験担当責任者（CSM）の役割を担う。

2.　臨床試験の実施計画と実施計画書等の関連文書の作成。

3.　PMDA及び/又は医師やその他のステークホルダーと臨床試験の進捗、方針等の実施に関する交渉を試験の立ち上げから終了後までの期間を通じた（結果の公表、承認申請準備含め）実施。

4.　実施中及び新規の臨床試験に関する管理業務

• 外部サプライヤーの選定

• マイルストンの明確化と進捗の管理

• 施設及び/又は外部サプライヤーとの契約書の作成とその締結

• EDCや紙の症例報告書を用いたデータ収集と社内システムを用いたデータ管理

• マイルストン及びその予算計画の作成とその管理

• 治験機器の管理

　以下、必要に応じて

• 解析計画の方針決定とその計画に沿った解析の実施

• データ公表に関する計画の立案と結果の公表

5.　試験担当責任者（CSM）の役割

6.　PMDA等に対する必要な報告及び対応

7.　社内の監査チームに協働し、監査対応

8.　外部の機関（PMDA信頼性保証課等）による適合性調査に対する対応

9.　必要に応じて、直属の上長及びビジネス戦略上の事業部に対する報告、相談、対応

＜求める人材＞

＊：必要用件　＋：推奨要件

職歴・資格

＊5年以上のJ-GCP/ISO14155、人を対象とする医学系研究に関する倫理指針、臨床研究法の関連業務

＊3年以上の外部サプライヤー（CRO、SMO等）の管理経験

＊プロジェクトマネジメント経験

＋医療関連の経験（看護師、薬剤師、技師等）

＋医療に関する知識を要する又は臨床開発に準じた業務経験

＋PMDA GCP適合性調査の経験

＋CRA経験

＋デバイス、疾患の知識

知識

＊J-GCP/ISO14155

＊人を対象とする医学系研究に関する倫理指針、臨床研究法及びその他の関連通知に関する知識

＋統計解析

＋データマネジメント

スキル

＊異なる意見を受容できる高いコミュニケーション能力

＊高い問題解決力や情報分析能力

＊ロジカルシンキング

＊コンプライアンス及びクォリティを念頭においたビジネス思考

＊英語：ビジネスレベル（TOEIC 800程度）

＊日本語：ネイティブレベル

学歴

＊学士号

＋博士又は修士（理系）

コンピテンシー

＊英語でコミュニケーションをとったり、会議を進行したりする意欲があること

＊多文化背景を持つ複数のステイクホルダー間の調整を行う意欲があること

＜働き方＞

正社員、フレックスタイム、出張・外勤は全体の15%程度

ベネフィット

メドトロニックでは、会社の成功と社員の成長は共にあるべきであると考えています。社員一人ひとりの経済的、身体的、精神的な幸せを高められるような、充実した福利厚生と報酬プログラムを用意しています。

• 年間最大36万円の育児費用補助

• 家族に介護が必要になった場合や養子縁組の際などに6週間取得できる休暇制度

• ベビーシッターや保育園のマッチングサービス

• メンタープログラムやe-learningなどを含むキャリア開発

• 女性の活躍を支援する社内キャリアネットワーク

• 自社株購入制度　etc.

その他

＜諸手当＞

• 通勤手当、勤務時間外手当、休日勤務手当　etc.

＜休日＞

• 土曜日、日曜日、祝祭日　etc.

＜休暇＞

• 年次有給休暇、公傷病休暇、生理休暇、産前産後休暇　etc.

＜勤務時間＞

9：00～17：30

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＜About Department＞

The Clinical Research Medical Science Department (CRMS) is responsible for the evaluation/assessment of the safety and efficacy of new medical devices through domestic and global clinical research/trial and the submission to MHLW (PMDA) for the manufacturing and marketing approval. For the devices that obtain manufacturing and marketing approval, investigation/research is conducted to collect, detect, and confirm information on the quality, efficacy and safety of the medical device when used in general practice, these are information regarding the appropriate use and safety of the product which could not be collected during a clinical trial. Also, by conducting studies such as Post Market Release studies, new evidence are collected to investigate further clinical application for Medtronic products.

CRMS department in Medtronic is conducted by mainly 3 entities, Clinical Research, Clinical Solutions, and Evidence Solutions. Clinical Research covers all Pre-market projects, Clinical Solutions covers monitoring activities and safety reporting activities, and Evidence Solutions covers post-market projects.

Clinical Research Department consists of three divisions, the first to cover CRM/CAS, the second division to cover SH/CRDN/PVH, and the third to cover all MS/NS related medical devices, and is responsible to be the center of a project, communicating and cooperating with domestic/foreign counterparts and departments.

＜Job Summary＞

A Clinical Study Manager (CSM) is responsible for managing and leading a clinical team to execute different types of clinical studies such as clinical trials and post market release studies, develop strategies for assigned clinical study considering business circumstances and regulatory requirements, and collaborate with not only internal team members including domestic/global study team, regulatory affairs department, but also external parties including suppliers, government agencies, medical staffs and physicians.

＜Main Responsibilities＞

You will mainly conduct Study Management activities for studies assigned to your designated Clinical Research Division. Your responsibilities include the following:

1.　In charge of the Clinical Study Manager (CSM) role as a primary contact of assigned clinical study

2.　Develop a clinical study plan and create study execution documents.

3.　Work closely with stakeholders including PMDA and/or investigators throughout all the phases of clinical study and negotiate study progress and study execution plans with them.

4.　Management of ongoing/new clinical research/trial.

• Selecting external suppliers

• Clarifying milestones and managing the study progress

• Create and execute agreements with investigational sites and/or external suppliers.

• Contributing in data collection using EDC or paper CRFs and data management using internal systems

• Creating and overseeing milestones and budget planning/management

• Overseeing investigational device management

　Secondary duties/responsibilities as applicable:

• Contributes in creating Statistical Analysis Plan and conducting the analysis according to plan.

• Participate in data publication planning, and publishing outcomes.

5.　Overseeing PMDA reporting and responses.

6.　Working with the internal audit team for internal audits

7.　Work with external organization (such as PMDA office of conformity audit) for inspection

8.　Reporting, consulting and working with superiors and Operating Units (OU) as appropriate

＜Job Qualifications＞

＊must have, +Nice to Have

Job Experience / Qualifications

＊At least 5 years of work experience related to J-GCP/ISO14155, Ethical Guidelines for Medical and Health Research Involving Human Subjects, and Clinical trial Acts.

＊At least 3 years of experience managing external suppliers.

＊Project Management

＋Experience in the medical field (Nurse, Pharmacist, Technicians and etc.)

＋Work experience with Clinical Research or work requiring medical knowledge

＋Experience with PMDA GCP conformity inspection

＋CRA experience

＋Knowledge of medical devices and diseases

Knowledge

＊J-GCP/ISO14155

＊Ethical Guidelines for Medical and Health Research Involving Human Subjects, Clinical trial Acts and other related notifications

＋Statistical Analysis

＋Data Management

Skills

＊Excellent communication skills embracing diversity

＊Strong problem-solving skills and analytical skills.

＊Logical thinking skills

＊Business minded with compliance and quality-oriented

＊English：Business Level（TOEIC score around 800）

＊Japanese：Native Level

Education

＊Bachelor’s Degree

＋Doctorate or Master’s degree (Scientific field)

Competency

＊Willingness to communicate/facilitate meetings in English

＊Willingness to arrange between multiple multi-cultural stakeholders

＜Working Style＞

Full time, Flexible Work Arrangement with 15% of the time traveling.

Benefits

At Medtronic, we believe that the success of the company and the growth of our employees go hand in hand. We offer comprehensive benefits and compensation programs designed to enhance the financial, physical, and mental well-being of each employee.

• Up to 360,000 yen per year in childcare subsidies

• Six weeks of leave for family members who require nursing care or for adoption

• Babysitter and nursery school matching services

• Career development, including mentor programs and e-learning

• Internal career network to support women's advancement

• Employee stock purchase program etc.

Others

＜Allowances＞

• Commuting allowance, overtime allowance, holiday work allowance, etc.

＜Holidays＞

• Saturdays, Sundays, public holidays, etc.

＜Vacation＞

• Annual paid leave, sick leave, menstrual leave, maternity leave, etc.

＜Working Hours＞

• 9:00 a.m. to 5:30 p.m.

 

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

 

 

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.  We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
 

 

 

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. 
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here