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Project Management Specialist

チームとプロジェクトマネージャーと協力し、プロジェクトを遂行

募集業種
Project Management Specialist
職務内容
・Responsible to work collaboratively with project team(s) on all project-related issues to ensure all activities are conducted in highest quality standards, in compliance with ICH E6 GCP and applicable local regulatory requirements as well as to meet/exceed sponsor's expectation, under the supervision of project manager(s) ・Responsible to work closely with project team(s) and project manager(s) to oversee daily operations and management of activities associated with assigned project(s) from concept to completion of final study report and ensure project goals are achieved ・Responsible to work closely with project team(s), project manager(s), external parties (including sponsor), to support start up activities (such as vendor management, logistics management, clinical supplies and investigational product logistics as well as systems set up) to ensure swift study start up ・Support project(s) in the capacity of "Project Manager Assistant" (PMA) and/or "Sub-Clinical Project Leader" (Sub-CPL) and/or "Clinical Project Leader" (CPL) and undertake all or partial responsibilities and tasks as detailed in SOP, whenever designated by Project Manager ・Support project team(s) in developing and accurately updating/maintaining of clinical or relevant systems to track the compliance, finance status and performance of the project and site(s) within project timeline ・Support and/or conduct monitoring and co-monitoring activities, as required, under the supervision of project manager(s), CPL(s)/Sub-CPL(s) ・Support project team(s) in developing , compiling and/or reviewing of all project-related regulatory, monitoring and administrative documents as required, under supervision of project manager(s), CPL(s)/Sub-CPL(s) ・Support/assist in feasibility studies, site and investigator identification as required ・Assist to set up, review and maintain project files to ensure compliance to ICH E6 GCP, applicable local regulatory and project requirements ・Support/assist in regulatory search in related to clinical trial planning, conducting and product registration ・Support Company's operations by assisting/coordinating and conducting orientation and applicable training for new employees as required
経験/資格
・Minimum bachelor degree (major in nursing, pharmacy or other science-related background) from a recognized institution, and/or equivalent combination of training and experience ・Minimum 4 years of experience in clinical research in healthcare, pharmaceutical and/or CRO industry or minimum 3 years direct experience and good track records in assisting clinical project planning, coordinating and management with preferably experience in assisting multi-national project planning, coordination or management ・Preferably has experience in coordination and/or preparation for site/CRO audit ・Preferably has experience in clinical study monitoring and co-monitoring ・Strong computer/technology skills including MS Word, MS Excel, PowerPoint ・Effective written and verbal communication skills, preferably with good command of English in addition to Japanese. ・Good understanding of cross-functional processes, clinical trial processes and the regulatory environment
勤務地
東京

企業データ

会社名
非公開 まずはエントリー下さい。
設立
2012年
資本金
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従業員数
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事業内容
・医薬品開発受託事業 ・医薬品製造受託事業 ・医薬品営業受託事業 ・ヘルスケア事業
コメント
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