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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

＜ポジション名＞ Sr. Clinical Research Specialist 又は Clinical Research Specialist

＜勤務地＞ 東京　品川

＜部署＞ 臨床開発／メディカルアフェアーズ エビデンスソリューション3 （Japan CRMS ES3）

＜上司＞ Clinical Research Manager

＜部門について＞

Japan CRMS ES3は、ニューロサイエンス領域の事業部（CST、NM、NV、ENT）、メディカルサージカル領域の事業部（Surgical、ACM、Endoscopy）が扱う製造販売承認品のメディカルアフェアーズ活動を担います。

事業部や臨床現場の医師、海外クリニカルチーム等と協働・連携し、市販後の実臨床における製品の有効性や安全性に関する情報収集、医療現場でのアンメットニーズやエビデンスギャップを埋める市販後臨床研究の企画・実施や医師主導型臨床研究を支援し、戦略的に学会発表や論文投稿等により結果を報告していくことで、臨床エビデンスを構築し製品価値や信頼性をさらに高めていく役割を担います。

＜業務内容＞

市販後の臨床研究（製造販売後調査（PMS）、市販後臨床研究（PMR）や医師主導型臨床研究（ERP）など）に関し、以下のような業務を実施していただきます。

• 製造販売後調査（PMS）および市販後臨床研究（PMR）の計画立案と研究推進

• 医師主導型臨床研究（ERP）の医師への概要説明、施設契約および進捗管理

• 事業部のマーケティング戦略に基づくエビデンス創出プランの立案と実施

• 国内および海外の社内外関係者との良好な関係構築

• 下位あるいは低経験者へのティーチングならびにコーチングによる育成

• その他、組織やプロジェクトに必要な業務

＜Must Haves＞

Job Experience

• 医療機器会社、製薬会社、またはCROでの5年以上の臨床開発への従事経験

· プロジェクトマネジメントの知識・経験がありクロスファンクショナルなチーム主導経験

• その他、組織やプロジェクトに必要な業務

Skill / Knowledge

• GCP、GPSP省令に関する深い知識

• 英語での業務関連文書の読解、作成スキル

• 論理的思考力と問題解決スキル

• 優れたコミュニケーション能力（英語の場合、Globalとの会議にて発言できるレベルが望ましい）

• 論文精読、統計解析に関する基礎的な知識

Competency

• 自発的に考え能動的に行動できる能力

• チームワークを重視し、協力して業務を遂行できる能力

• 積極的に学び続ける姿勢

Education

• 学士以上（医学、薬学、看護学、生命科学、工学関連分野が望ましい）

＜Nice to Have＞

Job Experience

• 耳鼻科、精神・神経・呼吸器・脳・血管領域、消化器・泌尿器・婦人科領域、整形領域に関する実務経験

• PMDA相談、照会事項等の対応経験

• PMDAの適合性書面調査（GCP, GPSP省令）の対応経験

• その他、組織やプロジェクトに必要な業務

Skill / Knowledge

• ISO 14155の知識

• 人を対象とする医学系研究に関する倫理指針の知識

• 臨床研究法に関連する知識

• 薬事・品質・マーケティング・R&Dエンジニアの知識

＜労働条件のうち入社後変更の範囲について＞

• 従事すべき業務：会社の定める業務

• 就業場所：会社が指示する管轄エリア

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 (http://www.medtronic.com)

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.

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

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.

This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here (https://www.e-verify.gov/employees) .

For updates on job applications, please go to the candidate login page and sign in to check your application status.

If you need assistance completing your application please email AskHR@medtronic.com

To request removal of your personal information from our systems please email RS.HRCompliance@medtronic.com