At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll 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

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

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CROSMO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

9001730

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:

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

a clinical study plan and create study execution documents.

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.

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.

PMDA reporting and responses.

with the internal audit team for internal audits

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

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

EnglishBusiness LevelTOEIC score around 800

JapaneseNative Level

Education

Bachelors Degree

Doctorate or Masters 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 360000 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 womens 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.

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 95000 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