Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

A Day in the Life

＜職務内容サマリ＞

本ポジションは国内外の不整脈医の先生方や関連部門と連携を取りながら、製造販売後調査（PMS）、製造販売後臨床研究（PMR）、企業スポンサー型の医師主導臨床研究（ISR）等のプロジェクトの中心的な役割（Clinical Research Manager: CSM）として関連規制や社内SOPに基づきチーム管理・運営を担います。また関連業務の中で、サプライヤー、PMDA等の政府関係者、医師等の医療関係者などの外部関係者や品質保証や薬事部などの国内外の関連部門と協働して臨床研究結果に関するPublication戦略（学会発表や論文公表等）、さらにそれらを用いた薬事戦略を担います。加えて、社内外の関係者に関連ガイダンス、コーチング、トレーニング等の提供を担います。

＜職務内容＞

部門・職務紹介

Clinical Research and Medical Science (CRMS)のMedical Science/MS Group1は循環器領域で不整脈治療に貢献する医療機器（ペースメーカ、ICD/CRT、ICM、カテーテルアブレーション等）を取扱うEPT（CRM/CAS）事業部のエビデンス構築、メディカルアフェアーズ業務を担っているチーム組織です。

本ポジション（Sr. Clinical Research Specialist）は国内外の不整脈医の先生方や関連部門と連携を取りながら、製造販売後調査（PMS）、製造販売後臨床研究（PMR）、企業スポンサー型の医師主導臨床研究（ISR）等のプロジェクトの中心的な役割（Clinical Research Manager: CSM）として関連規制や社内SOPに基づきチーム管理・運営や予算作成・管理（研究施設やベンダー等の選定含む）を担います。また関連業務の中で、ベンダー、PMDA等の政府関係者、医師等の医療関係者などの外部関係者や品質保証や薬事部などの国内外の関連部門と協働して臨床研究結果に関するPublication戦略（学会発表や論文公表等）、さらにそれらを用いた薬事戦略を担います。加えて、社内外の関係者にクリニカル関連（担当プロジェクト以外も含む）のガイダンス、コーチング、トレーニング等の役割を担います。

特にGCP/GPSP、倫理指針等の臨床研究の関連規制を熟知している方、臨床研究に関するプロジェクトマネージメント・リードに長けている方、サイエンティフィックなデータ分析・公表に関心のある方、国内外の関連部署や医療関係者の方と献身的かつ戦略的なコミュニケーション（英語含む）ができる方を歓迎いたします。

必要な知識と経験:
求める人材：

＊：必須要件、+：推奨要件

□ 職歴・免許

＊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、臨床研究法に関連した職務

＊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又はリードモニター経験

＋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 730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）

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. 

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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).

Who We Are

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.

What We Do

We change lives. Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.

We build extraordinary solutions as one team. With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.

This life-changing career is yours to engineer. By bringing your ambitious ideas, unique perspective and contributions, you will…

• Build a better future, amplifying your impact on the causes that matter to you and the world

• Grow a career reflective of your passion and abilities

• Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning

How We Are Different

These commitments set our team apart from the rest:

Experiences that put people first. Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.

Life-transforming technologies. No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.

Better outcomes for our world. Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.

Insight-driven care. Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.

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