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新着求人 データマネジメント  (DM-25)
募集職種 外資系製薬メーカーの Data Monitoring & Management Group Lead
(Line Manager)(専門管理職)
勤務地 東京
会社概要 非公開
求人要件 1.主な職務における成果責任/ Description of Primary Role & Responsibility
1. Manages human and resource investments for group, provide administrative and technical oversight of group and develop people, including motivation, career development and performance management
2. Serves as point of contact for providing responses to internal audits as well as regulatory inspection with regard to data management activities
3. Develops and maintains expertise to ensure appropriate study database design on new and legacy business technology (e.g. DataLabs, OC, InForm and Rave) and provides technical input to Global organizations (e.g. DMM, CDMM, COE) and the vendors.
4. Serves as a local focal point to implements data conformance strategy as defined by COE Clinical Trial Solution involving submissions, acquisitions and divestitures of the data integrated into the CAL
5. For local assets, mitigates/arbitrates asset level data management technical and process issues with CROs, DMM and CDMM
6. Drives lessons learned to continuous improvement of data management practices across the organization including internal customers and CROs
7. Leads new ** clinical/PMS data collection environment (i.e. NextGen CDMS, Rave) by successful implementation and maintenance of the database systems and related processes
8. Provides input to DMM to continuously improve ** processes/systems and share issues associated with data management for resolutions.
9. Works with BPOs to review performance metrics against targets to ensure program deliverables are being met and productivity is aligned with ** expectations
10. Maintains solid partnership with Global BDM, COE Clinical Trial Solution and CDMM to ensure global alignment
11. Works with global organizations to ensure appropriate data standards, system and processes are used and implemented consistently across the programs
12. Peers with Line Leads in Japan BDM and contribute to its achievements as a whole.
13. Serves as a local subject matter expert and information resource on all aspects of standards development that includes CDISC standards (CDASH, SDTM, and ADaM), regulations, processes, business policies and any applications supporting standards development and change control
14. Leads discussion around new system establishment/implementation in Japan (e.g. CDSIC implementation) with industry and the regulatory agency.
15. Leads the strategy and implementation for CDISC-compliant data in Development Japan
16. Leads global discussion around CDSIC strategies for J-NDA with Global DMM, SPA and COE and provide input to create comprehensive plan to implement the new standards and convert legacy data.
2.応募資格/ Qualifications
Job Rank: Manager
Education/Certification: Bachelors, Masters, or advanced degree (PhD, MD) in biological sciences, statistics, IT, medicine or related field, or equivalent education or experience in related scientific discipline
English Skill: Level at which s/he can discuss, debate, negotiate with global colleagues or external customers about complicated or controversial issues. More than TOEIC 730 at least
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