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Associate Director or Manager, Outsource and Quality Management/ アウトソースおよびクオリティーマネジメント 主席部員または 課長代理

Apply Now Email Me Job ID R0012289 Date posted 10/25/2019 Location: Osaka, Japan

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Job Description

Please note that this job requires native level Japanese language command not only in speaking, but also in business writing and reading.




Takeda is unwavering in our commitment to patients. With the patient at the center of everything we do, we continue to innovate and drive changes that will better their lives - we’re looking for like-minded professionals to join us.

Today, we are the number one pharmaceutical company in Japan and a global industry leader, with approximately 30,000 employees around the world. We are united by our four priorities (patient, trust, reputation and business) and Takeda-ism (Integrity, Fairness, Honesty and Perseverance) , and strive towards better health and a brighter future for people worldwide.


Development Excellence Operations is established as new organization from Japan development center for cross-functional outsourcing management to accommodate recent business model change.

We have the following four essential teams which are closely collaborating to maximize operational excellence (quality, speed, cost and innovation). We are leading in the operational excellence to deliver innovative treatments to patients through comprehensive partnership management while enhancing Takeda's Pipeline.

Procurement:We are responsible for procurement works by managing an efficient/effective procurement process/system.

Outsourcing:We are leading operational excellence to work with development project team through comprehensive outsourcing management.

Engagement Mgm.:We deliver the best partnership management to maximize our partners' performance.

Quality Mgm.:We have established, implemented and oversighted quality management system for development operations








Responsible for timely and high-quality Data Management deliverables supporting the Takeda portfolio.

Establish asset and study level strategies and services in Data Management, including excellence in the application of standards.

Conduct oversight using, predictive Data Monitoring practices from database activation through database release and submission.

Contributes to the management of vendor partnerships to verify contractual assumptions in the study SOWs including the verification of monthly invoices.

Acts as a first point of contact for CRO partners seeking sponsor input on study level problem solving and decision making related to DM activities.

Serves as an expert for clinical Data Management best practices and acts as an ambassador on CDISC standards.












Participates in study level vendor oversight activities. Represents Data Management function on the Clinical Sub-team ensuring aligned expectations between the CRO and Takeda for all data related deliverables, especially in support of key decision points and regulatory submissions.

Serves as a first point of contact for CROs partners when collaboration is needed to ensure established DM related milestones and deliverables are met with the highest degree of quality.

Partners with appropriate stakeholders and CRO partners to mitigate and resolve risks.

Acts as a process expert for operational and oversight models.

Maintains SOPs, process maps and templates and timelines to support functions operational and oversight models.

May prepare metrics to support the function’s KPIs.

Tracks study deliverables and evaluates study metrics to mitigate risk for major data management deliverables and milestones and to ensures achievement of them in coordination with other functions including the Therapeutic Area Units, Clinical Operations, Statistical Programming and Statistics.

Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents

Verifies external Data Management SOWs and timelines to ensure accuracy of invoices, investigates variances and supports forecasting.

Participates in preparing function for submission readiness and represent Data Management function in a formal inspection or audit.

Other duties as assigned




•BS/BA required preferably in a health-related, life science area







•A minimum of 5  years data management experience.

•Proven track record of strong project management skills and experience managing data management activities for large drug development programs

•Ability to handle multiple development programs simultaneously.

•NDA/CTD Experience.






•Microsoft Officeのソフトフェアの高度な知識を有している






•Strong knowledge of electronic data capture and data warehouse technologies as applied to clinical trials.

•Strong working knowledge of (e)CRF design and data management functions/activities as applied to standards library development and maintenance.

•Good understanding of CDISC standards, and experience implementing standards.

•Strong knowledge of clinical study reporting requirements including SAS programming.

•Advanced knowledge of office software (Microsoft Office).

•Solid understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes.

•Advanced knowledge of PMDA  and ICH regulations and industry standards and quality control principles.

•Experience in medical coding in the pharmaceutical/biotechnology industry including knowledge of coding tools.

•Good working knowledge of general statistical programming processes and practices.

•Advanced knowledge of medical terminology, medical coding, laboratory reference ranges, clinical diagnostic procedures, anatomy/physiology and nature of disease processes.

















賞与: 原則年2回

勤務時間:本社(大阪市中央区・東京都中央区)9:00~17:30 、工場(山口県光市・大阪市淀川区)8:00~16:45 、研究所(神奈川県藤沢市)9:00~17:45






Empowering Our People to Shine 


Osaka, Japan

Worker Type


Worker Sub-Type


Time Type

Full time

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