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** **JOB TITLE:** 　 **Clinical Monitoring Manager** **DEPARTMENT:** 　 **Clinical Research and Medical Science Clinical Solutions Study Monitoring** **REPORTING TO:** 　 **Clinical Research & Medical Science Director** ************************************************************************************************** + 職務目的 + 複数試験・複数施設にわたってモニタリングチームのリーダーとして市販前・市販後のモニタリング機能を統括する + 各クリニカルプロジェクト（市販前／市販後臨床試験）の成功のために、事業部や他の臨床チームとのクロスファンクショナルな協業をリードする + 部内のリーダーシップチームのメンバーとしてチームのガバナンスやタレントの育成に貢献する + 組織上の位置づけ・管理範囲 + 報告ライン：Clinical Research & Medical Science Director + 直轄：モニター8~10名（正社員及び派遣社員） + 業務上の責務 + モニタリング責任者としての業務遂行の責務 + ピープルマネージャーとしての人材の教育・監督責務 【職務内容】 + 試験デザイン等に基づき、モニタリング戦略及び計画の策定・改定を指導し、施設ごとのマイルストーンを設定・社内合意形成を主導する + モニターのアサイン計画と業務負荷を統括し、教育・メンタリングを通じて品質基準の順守を確保する + 定期的にモニタリング報告書の内容をレビューして品質を確認するとともに、モニターの習熟度を評価し、必要に応じて教育を実施する + モニター、並びにリードモニターが実施する下記の業務を監督する + IRB／EC、契約、必須文書の回収・点検を実施し、試験実施施設を立ち上げる + 臨床試験の円滑な進捗のため、施設医師や試験協力者、CROなどの外部機関との連携関係を構築・維持する + モニタリング計画並びにプロトコールや各種規制の遵守状況を監視し、逸脱発生時には是正・予防措置を実施する + 有害事象の運用を監督し、EDC入力内容及び書式14の適切性し、並びに報告期限を遵守する + データ入力およびクエリ解決の進捗を管理し、データロックに向けた完了率達成を目指す + 施設文書の品質管理を行い、eTMF内の施設文書の完全性・充足性を管理する + 各施設を、常時査察に耐えうる状態に維持し、施設関連の監査・査察指摘事項があった際の是正・予防措置を実施する + 施設訪問を計画し、未解決のアクションアイテムを解消する + スタディーチームと協業し、登録促進や患者リテンション向上施策の立案と実装を実施する + 勤務地　　品川オフィス + 出社頻度　会社規定に従う + 応募要件 + 10年以上の臨床試験モニター経験を有すること。（医療機器、医薬品を問わない） + うち、5年以上のリードモニター経験を有すること。 + 応募時点では、市販前・市販後いずれのリードモニター経験でも可。 + ネイティブレベルの日本語力、ビジネスレベルの英語力を有することが望ましい **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