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DM(データマネジメント)求人一覧

現在、公開されている求人です。
【新着求人情報】 ・・・DMT-01  が新たにオープンとなりました。

※下記求人に関しての問い合わせはこちらへ
          2019/01/17
状況 求人No 資本金 勤務地 スペック 英語力
NEW  DMT-01 4億 外資 東京 Senior Specialist, Data Statistical Science (Data Management)
【Purpose】
・The position is responsible for providing oversight and support to Japan clinical development projects in the area of data management.
・These services are supplied in the context of a cooperative, project-oriented effort and included data capabilities in general planning and execution of clinical trials, statistical analysis and reporting of the data from these trials, and regulatory submissions and inspections.
【Major Responsibilities】
• Design Case Report Form (CRF) according to CDISC.
• Prepare required documents for Data Management.
• Prepare database for Clinical Trial.
• Provide high quality clinical data set for analysis.
• Introduce and maintain IT systems for Data Management such as EDC, ePRO and IRT.
• Mentor other specialists.
【Qualifications】
• At least 5 years’ of experience in pharmaceutical R&D including at least 3 years’ experience in Data management and statistics areas.
• A bachelor’s degree in or equivalent knowledge of statistics/mathematics, pharmacy, biology, pharmacology or related scientific field focused on quantitative skills. A master’s or doctor’s degree is more favorable.
• Proficient in English communication skills with global members (TOEIC 600 or more or equivalent)
• Good leadership skills globally and locally as defined by ** core leadership behaviors.
  DMT-02 72億 外資 東京 データマネージャー
【Basic purpose of the job】
Contributes to the development process for new substances and development and promotion of drugs on the market by providing expertise, expectations, direction and oversight for Clinical Data Management (CDM) deliverables. Takes a lead role with internal and external partners and represents the company at meetings with clinical investigators and in the interaction with Contract Research Organizations (CROs) and external vendors in all aspects of data management for assigned trial(s). May provide input into CDM standards and process developments.
Assumes one or more of the following roles demonstrating the required expertise and capabilities as:
- Trial Data Manager (TDM)
- Central Monitor (CM)
Or developing expertise and capabilities under supervision as:
- Project Data Manager (PDM), as an associate PDM or supporting a local submission (e.g. in Japan or China)
- Risk Based Quality Management (RBQM) Business Partner (BP), e.g. as an associate RBQM BP or for a trial of low complexity
【Planning / Organisation】
• Excellent organisational skills, problem solving abilities, negotiation skills, time management skills and initiative.
• Must be able to work independently as well as as part of a team.
• Able to effectively manage multiple assignments and adapt flexibly to changing priorities.
• Able to produce robust timelines and action plans, regularly review and follow up on progress and take decisive action in terms of follow up activities with local and global trial/project teams. Ensures work is completed effectively.
Communication: • Strong communic
ation skills with the ability to simply summarise complex information. Ability to use a wide range of communication techniques and media (written and verbal). Confident and persuasive communicator to ensure that the message is clear and well understood.
• Ability to work collaboratively on multi-disciplinary project teams and to pro-actively manage relationships with external vendors.
• Mindful of local, global, internal and external cultures to ensure that messages are received positively and effectively.
• Ability to lead and facilitate meetings.
• Ability to develop and deliver (technical) training.
【Language skills】
English (read/write/speak):fluent
  DMT-03 648億 外資 東京 Data Monitoring & Management Group Lead (Line Manager)(専門管理職)
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
【資格・能力要件】
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
  DMT-04 500億 国内 東京 データサイエンス(データマネジメント担当)
【募集要項】
データマネジメント担当者として以下の業務を遂行する。
・オンコロジー領域の臨床試験のデータマネジメント計画立案
・Electronic Data Capture (EDC) をはじめとするデータマネジメント関連ツールの構築、運用
・eCRF、データ品質管理計画の立案、データマネジメントCROの業務管理
・承認申請時に必要なデータマネジメント関連の規制当局対応
【必要な経験・スキル】
・臨床開発に関する基礎知識ならびにICHや国内外の規制当局が公表している各種ガイドライン等の理解
・臨床試験におけるデータマネジメント業務の知識、業務経験
・CDISC標準(特にSDTM)に関する基礎的な知識
・ITならびにSASプログラミングに関する基礎的な知識
・オンコロジー領域のデータマネジメント業務の経験があればなお望ましい
・チームで協業可能なコミュニケーション力と調整力
・英語で会話や議論ができる能力(目安としてTOEIC 650点以上)
  DMT-05 10億 外資 東京 R&D Clinical Data Manager (Senior Specialist level)
【仕事内容】
臨床試験のデータマネジメント業務をご担当いただきます
・国内外CRO・その他ベンダーマネジメント(バジェットの管理を含む)
・CRF設計・データベースの構築指示
・データレビュー、コーディングレビュー
・電子データ申請準備、等
【資格】
(業務経験)
-医薬品開発に関する実務経験5年以上
-データマネジメントに関する実務経験3年以上。セットアップから申請・適合性調査までを中心となって実行した経験を有する
-社内外の海外の担当者との業務経験を有する
-業務改善等のプロジェクトをリードした経験を有する
※クロスファンクションのプロジェクト経験があると尚可
(知識・技能)
-データマネジメント業務を実施するための臨床的知識・規制要件を熟知している
-プロジェクト管理能力
-コミュニケーションスキル
・部門の代表として新薬開発のプロジェクトチームに貢献し、DMの視点から必要なインプットが出来る事
・海外を含む社内外の関係者と適切なコミュニケーションがとれる事
-データマネジメントシステムに関する知識・使用経験
-ビジネス英語(TOEIC 750点以上、または同等)
  DMT-06 298.4億 外資 東京 Group Manager, R&D Clinical Data Management Group
【POSITION SUMMARY】
Responsible for planning, validating, managing and maintaining the various components of the clinical data management function such as clinical data coordination.
Accountable for the efficiency of the department as well as the quality of the data managed, considering the business impact.
(PRINCIPAL RESPONSIBILITIES)
・ Oversee and manage the Clinical Data Management group activities.
・ Mentor, coach, train and develop group members.
・ Contribute to develop talents ex- CDM group member as required.
・ Assist the group member to evaluate performance and provide opportunities for growth.
・ Contribute to the implementation of process improvements while maintaining globally consistent processes.
- Develop and improve departmental procedures, processes and templates for continuous quality improvement, considering the business impact and the controlling of expenditures.
・ Develop sourcing strategy from drug project perspective.
・ Prioritize and assign projects, closely monitoring resource allocation and work schedule.
・ Evaluate and allocate JDML resources from functional organizations.
・ Develop department budget and monitor the controlling of expenditures for drug projects.
・ Interact effectively with stakeholders not only locally but also globally.
・ Lead cross-functional task force team as required.
(REPORTING RELATIONSHIPS)
Report to Director, Data Management Dept.
【資格】
(EDUCATION, EXPERIENCE & SKILL REQUIREMENTS)
Education level: University/Bachelors degree or equivalent.
Years of Experience: Generally requires (8-10) years related experience

 

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