e-医療機器　転職・仕事・業界　完全ガイド

Provide leadership and clinical expertise in support of new product clinical development and /or marketed product idication expansion.

■Key Responsibilities:
・Plan clinical affairs projects and activities with accountability for successful completion within scope of project deliverables
・Provide clinical expertise including establishing and approving scientific methods for design and implementation of clinical protocols, investigator's brochure, sponsor ICF, and reports/data presentations/publications.
・Prepare documentation for regulatory submissions required in Japan and other counties (if requested), and communicate with PMDA from the perspective of clinical science.
・Initiate, develop and maintain liaison among physicians/investigators, other medical professionals, Research Organizations (CRO's), hospitals and research institutions to manage clinical trials/registries from initiation through completion.
・Identify and evaluate clinical affairs process improvements and/or course correction/course alignment opportunities.
・Other incidental duties

■Key Responsibilities
・Create complex metrics to identify trends in data and remediation, utilizing tools (e.g., systems, reports) to assess need for training and provide recommendations to improve data status during study conduct
・Define and specify clinically complex data collection requirements (e.g., eCRFs, CRFs, edit checks and collection of external data) for assigned studies; including defining, performing, and coordinating user acceptance testing (e.g. test scripts and checklists) to ensure appropriate data are collected.
・Lead project management activities for multiple (multi-site and multi-cohort) projects to bring clinical studies on-line, including conducting project team meetings, establishing and maintaining project timelines, and communications to stakeholders.
・Develop and maintain Data Management deliverables including data management plans (DMPs), training materials and user aids in compliance with regulations
・Evaluate data errors and collection issues; provide guidance and recommendations to clinical team for resolution
・Perform Site/User Administration to allow access to the database, ensuring all users are qualified to access data base; may provide guidance on more complex access rights for users
・Lead development and review of SOPs, work instructions, and associated documents for CDM, including recommending revisions and updates to SOPs, participating in the development of user training.
・Other incidental duties assigned by Leadership

Key Responsibilities : Physician training グループのチームマネジメント

主な職務内容
・臨床教育チームの業務を管理・監督し、必要に応じてクロスファンクショナルチームを間接的に管理する。また、部門の成長戦略に沿った人材育成計画を策定する。また、経費予算を管理する。
・Physicianに対し必要な知識やスキル などを提供するべく、トレーニングやケースサポートプログラムの開発を及びマニュアルの作成に責任を負う。
・セールスマネージャーと協力して、販売戦略をサポートするために、主要顧客や潜在的な顧客に焦点を当てたトレーニングプランを開発する。

【Key Responsibilities】
・Analyze and evaluate changes in laws and regulations relating to IIS and identify the impact on X's and share recommendations internally
・Analyze and evaluate emerging medical treatments and clinical outcomes for products related to X's, and recommend where X's should change current processes.
・Review medical content in BU promotional materials, including educating marketing team on best approach to write medical related content
・Participate in the review and assessment of new IIS (Investigator Initiated Study) proposals while insuring compliance with Medical Affairs processes. Assist with preparing presentations for ensuring an informed review process of proposals
・Maintain the database for all IIS's, track milestones accomplishments and insure associated payments.
・Provide assessment to sites and investigators, determine challenges, and define mitigation plans. Provide regular updates to management and business unit partners on ongoing studies
・Other Incidental Duties

TAVIの安全性維持・向上のためのクリニカルサポート全般
・患者様スクリーニングサポート
・手術立ち会い
・術後のフォローアップ
・手術に関わる医療従事者向けの日常的な情報提供、トレーニングの実施

■具体的な業務内容
開発に関する一連のプロセスを経験し、「医療機器設計者」の第一人者に成長して下さい。
・自ら手を動かし実験データを蓄積し、設計者として技術的知見でテーマにアプローチをします。
・関連部門と連携し、開発コンセプトを構築してプロトタイプの検証と量産化に繋げます。
・自ら医療施設を訪問し、生の声（ニーズ・課題）を直接ヒアリングします。
・学会で新製品の特長を発表したり論文を投稿することもあります。

■この業務のやりがい
昨今、世界的にヘルスケアや医療機器に対する注目度が高まっています。
「患者様のQOL向上と医療発展に貢献している」という実感をもって仕事をすることができます。

＜取扱い商材＞
透析器（ダイアライザ-）、アフェレシス（血漿交換療法、持続緩徐式血液濾過療法、腹水濾過濃縮再静注法、等の治療）に使用する製品