e-医療機器　転職・仕事・業界　完全ガイド

Ensure 「A」 clinical study device documentation provides a valid source of device traceability and accountability data for regulatory submissions, reporting, and audits.

【Key Responsibilities】
• Lead in the investigation of all discrepancies by applying clinical protocol knowledge and develop processes to minimize possibility of recurrence
• Lead in assessing current process, identifying opportunities and implementing solutions to improve process efficiency within and across related functional areas
• Conduct in house and site (if applicable) reviews of associated documentation and lead in internal and Japan agency audits to ensure documents are compliant with Good Documentation Practices, 「A」 internal SOPs, and Japan regulations
• Resolve basic remote queries closures within electronic databases
• Analyze local clinical trial results and develop report for inclusion in the submission to PMDA
• Assess informed consent form (ICF) and collaborate with site (e.g., study coordinator) to ensure ICF includes all Japan regulations and 「A」 requirements
• Provide coaching and training to lower level employees
• 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】
・Analyze and evaluate changes in laws and regulations relating to IIS and identify the impact on 「A」 and share recommendations internally
・Analyze and evaluate emerging medical treatments and clinical outcomes for products related to 「A」, and recommend where 「A」 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