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Job Description

Company Overview
Clinical Data Scientist - Top Global Mega Pharma

Job Description
1.主な職務における成果責任/ Description of Primary Role & Responsibility

1. Serves as point of contact for providing responses to internal audits as well as regulatory inspections with regard to data management activities
2. Serves as a local focal point to implement data conformance strategy as defined by Global DMM Standards involving submissions, acquisitions and divestitures of the data integrated into the CAL
3. For local assets, mitigates/arbitrates asset level data management technical and process issues with CROs, DMM and CDMM
4. Leads new company clinical/PMS data collection environment (i.e. NextGen Clinical Trials, No Paper CRF in PMS) by successful implementation and maintenance of the systems (e.g. NextGen CDMS, PMS CDMS) and related processes
5. Works with BPOs to review performance metrics against targets to ensure program deliverables are being met and productivity is aligned with company expectations
6. Works with global organizations to ensure appropriate data standards, system and processes are used and implemented consistently across the programs
7. Applies and drives lessons learned to continuous improvement of data management practices across the organization including internal customers and CROs
8. Leads implementation of PMS data collection standards into each surveillance

Requirements
2.応募資格/ Qualifications

【資格・能力要件/ Desired Behavioral and Technical Skills】


<一般社員/専門管理職>
- Minimum of a Bachelor degree in biological sciences, statistics, IT, medicine or related field or experience in related scientific discipline
- Level at which s/he can discuss, debate, negotiate with global colleagues or external customers
- Flexibility and implementing change: Responds positively and constructively to changing situations and manages change by identifying opportunities and coaching self and others through the change
- Customer Focus: Identifies and builds effective relationships with customers and other stakeholders
- Ownership: Be accountable for data quality to internal and external customers to ensure confidence in data
- Knowledge in Clinical Development and Reexamination: Extensive knowledge of clinical development process and principle including the principles of GCP, GPSP and GVP
- Clinical Data Management expertise: Extensive knowledge of CRF/database design, database set-up, validation specs, query management, medical coding, SAE reconciliation, data browsing tools and outsourcing
- Communication: Shares best practices and any visible and/or potential issues with appropriate members in a timely manner

【職務経験】
Industry experience in order to have a thorough understanding of the processes associated with clinical drug development and reexamination (especially in supporting the data management and reporting components of regulatory submissions and product defence) as well as in developing/implementing new standards, systems and processes

【勤務地】 東京本社