求人一覧

CRAを募集しています。 【MAIN PURPOSE OF THE ROLE】 Experienced professional individual contributor that works under limited supervision. Applies subject matter knowledge in the area of Medical Affairs. Requires capacity to apply skills/knowledge within the context of specific needs or requirements. 【MAIN RESPONSIBILITIES】 ○ As the Experienced professional in the Medical Affairs Sub-Function, possesses well developed skills in overseeing the direction, planning, execution, clinical trials/research and the data collection activities. ○ Contributes to implementation of clinical protocols, and facilitates completion of final reports. ○ Recruits clinical investigators and negotiates study design and costs. ○ Responsible for directing human clinical trials, phases III & IV for company products under development. ○ Participates in adverse event reporting and safety responsibilities monitoring. ○ Coordinates and provides reporting information for reports submitted to the regulatory agencies. ○ Monitors adherence to protocols and determines study completion. ○ Coordinates and oversees investigator initiations and group studies. ○ May participate in adverse event reporting and safety responsibilities monitoring. ○ May act as consultant/liaison with other corporations when working under licensing agreements.

【Primary Function】 This role is responsible for managing study documentation and operational progress using Clinical Trial Management System, while maintaining the highest quality standards in clinical study execution. The position oversees documentation and study management support across clinical studies, including clinical investigations, post‑marketing surveillance, and clinical research, ensuring that all clinical study data comply with applicable regulations and SOPs. Leveraging prior CRA experience, this role as a Clinical Site Operation (In‑house CRA) provides the opportunity to oversee clinical studies from a broader perspective and to support both operational and quality aspects of study execution. Additionally, the role collaborates with APAC and global partners to drive continuous process improvements across the organization. We seek individuals who can maintain the highest level of quality in clinical studies while proactively addressing new challenges and contributing to innovation across the organization. This position is ideal for those who aspire to pursue various career paths in the future, including People Manager and Project Manager roles. 【Major Responsibilities】 ○ CTMS Management : Ensure compliance with clinical protocol and applicable regulatory requirements such as GCP, ISO14155 or GPSP through appropriate management, review, and maintenance of site-level TMF documentation in accordance with Work Instructions. ○ Study Management Supports: Maintain study progress in the CTMS. In partnership with Abbott assigned field staff and in-house personnel, coordinate and support site activation and site close-out activities for clinical studies, ensuring completion, accuracy, and compliance of all required documentation, processes, and study materials. ○ Study Document Development and Maintenance: Develop and update study specific documents in collaboration with internal/external personnel/parties.　 ○ Inventory Management for Clinical Trials: Manage clinical trial inventory in accordance with applicable regulations and internal procedures, including vendor management (e.g., courier and logistics providers), development of study -specific Inventory Management Plan, and coordination of shipment and return instructions for investigational devices.

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。 【具体的な業務内容】 ○治験治験、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 【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。