The Project Customer Operations team manages all aspects of system installation, start-up, customer training, field service analysis and support, and program optimization. Placement of a product in the hospital requires full time support for a four
JOB TITLE: SR. CLINICAL RESEARCH SPECIALIST DEPARTMENT: クリニカル・メディカルアフェアーズ 臨床試験信頼性保証 REPORTING TO: SR. CLINICAL RESEARCH MANAGER - 背景 臨床開発本部は、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で実施される臨床試験（治験）は、臨床開発本部、Medical Clinical Regulatory Solutions（MCRS）及びCorporate Clinical Quality Compliance(CCQC)の３部門体制にて実施され、MCRSは主にモニタリング、安全性情報管理を、CCQCは監査を担います。 臨床開発本部に所属するCVG/DIB Clinical担当は、循環器領域および糖尿病関連の医療機器を担当製品とし、国内外の関連部門と連携を取りながらプロジェクトの中心的な役割を担います。 - 要約 海外で実施された臨床試験（国際共同試験を含む）の資料（以下、海外臨床試験資料）を製造販売承認申請の審査資料（以下、申請資料）として利用する際の準備、適合性書面調査及びGCP実地調査に対応する。製品領域は、循環器領域から脳神経疾患領域など多岐に渡る。海外の臨床試験チーム、社内の臨床試験チーム及び薬事部などの関連部署と協働すると共に、業務の進行を担う。 - 業務内容 業務運営 本担当は日本法人内の薬事部門、臨床開発部門、海外臨床試験チームと協働し、これらをとりまとめ主導し、下記の業務を遂行する。 適合性調査に係る情報の共有 本邦の信頼性基準、GCPに対する懸念に対する対応 2.
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
