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＞ Senior Clinical Research Specialist(モニター職)** **＜勤務地＞ 東京または大阪　※担当施設の対象は全国となります** **＜部門について＞** モニタリング部門は、日本のCRMS部門（Clinical Research & Medical Science）と連携し、臨床研究の推進を支える重要な役割を担っています。治療領域ごとにグループ制を採用し、製品や疾患への深い理解を基盤に、試験の精度と効率を高めています。施設マネジメント全般を担当し、治験実施医療機関との強固な関係構築を通じて試験環境を最適化します。契約管理、進捗確認、品質保証、リスクマネジメントなど幅広い業務を包括的にサポートし、規制要件と倫理基準を遵守した運営を徹底しています。CRMS部門と一体となり、科学的エビデンスに基づく価値創出と患者安全を最優先に、革新的な医療の提供に貢献しています。 **＜業務内容＞** 治験の安全性・信頼性を担保し、日本の規制に適合した効率的な試験運営を支えるため、以下のような業務を実施していただきます。 + 治験、市販後臨床研究および市販後調査の計画・実施・進捗管理と報告書作成 + 担当施設における手続き業務、モニタリングならびに監査対応 + 関連文書の作成および確認 + 内部・外部関係者との良好な関係構築 + 重篤有害事象や逸脱の報告と対応、および医療機器の不具合報告と対応 + 担当試験のモニターチームのリード (リードモニター業務) + 下位あるいは低経験値モニター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7年以上の治験モニター経験 + 3名以上のモニターチームのリード経験 + 大学病院等の基幹病院の担当経験 Skill / Knowledge + GCPに関する深い知識 + 英語でのSOPや業務関連文書の読解、モニタリング報告書作成スキル + 高いコンプライアンス意識と品質意識 Competency + 優れたコミュニケーション能力と問題解決スキル + 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 Haves＞** Job Experience + 循環器や心臓血管領域の担当経験 + 担当試験の疾患領域におけるKOLマネジメント経験 (KOL施設担当モニター含む) + 役割を持ったPMDA対面助言の経験 + 役割を持った薬事申請におけるPMDA対応経験 Skill / Knowledge + ISO 14155の知識 Competency **＜Working Style＞** + 勤務形態: 出勤と在宅勤務のハイブリッド (最低出勤回数：1回/月) + 出張: 宿泊を伴う出張および突発的な外勤への対応が可能であること + 会議: グローバル会議への早朝あるいは夜間参加が可能であること + 緊急対応: 重篤有害事象発生等への迅速な対応が可能であること **_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　 **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