Staff, Clinical Data Scientist (PMS)
- 採用企業名
- ファイザーR&D合同会社
- 職種
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メディカル・バイオ - メディカルデータマネジメント
メディカル・バイオ - 統計解析
メディカル・バイオ - 製造販売後調査（GPMSP）
- 雇用形態
- 無期雇用
- 勤務地
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東京都
- 仕事内容
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...【詳細を見る】
Position Purpose
Clinical Data Scientist (CDS) serves as point of contact for data management strategy and operations in Pfizer Japan and provide central accountability for ensuring timelines and deliverables to be met with consistency, efficiency and quality.
Primary Role & Responsibility
Serves as point of contact for providing responses to internal audits as well as regulatory inspections with regard to data management activities
Mitigates/arbitrates technical and process issues on PMS data management with CROs and solution vendors
Leads new Pfizer PMS data collection environment by successful implementation and maintenance of the systems and related processes
Works with BPOs to review performance metrics against targets to ensure program deliverables are being met and productivity is aligned with Pfizer expectations
Ensures appropriate data standards, system and processes are used and implemented consistently across the programs
Applies and drives lessons learned to continuous improvement of data management practices across the organization with internal/external customers
Leads implementation of PMS data collection standards into each surveillance■休日：完全週休二日制, 祝日, 年末年始, 土, 日
- 求める経験
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...【詳細を見る】
Desired Behavioral and Technical Skills
Behavioral Skills
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.
Technical Skills
Clinical Data Management expertise : Extremely Extensive knowledge of clinical development process and principle including in-depth knowledge and understanding of the principles of GCP/GPSP as well as CRF design, database design and set-up, query management and validation specs, data browsing tools and outsourcing
Communication: shares best practices and any visible and/or potential issues with appropriate members in timely manner.
Experience
Industry experience in order to have a thorough understanding of the processes associated with clinical drug development and operations (especially in supporting the data management and reporting components of regulatory submissions and product defense) as well as in developing/implementing new standards, systems and processes.
Education
Minimum of a Bachelor degree in biological sciences, statistics, IT, medicine or related scientific discipline.
Language
Level where they can discuss, debate and negotiate with global colleagues and external customers
ファイザー日本法人では、2008年以降社内外に対して禁煙啓発や支援活動に取り組んできており、2019年までに社内の喫煙率を0％にすることを目指しております。
誠に勝手ながら、応募時点で喫煙者の方のご応募はご遠慮いただいております。■職種未経験者：不可
- 年収
- 600万円-1000万円
- 語学力
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英語力：中級以上英会話及び英語ライティングスキル （TOEICスコア 600点以上（必須）、730点以上（尚可）） / English verbal communication and writing skill (TOEIC score more than 600 (must), or more than 730 (preferred))
