医薬品の臨床開発におけるデータマネジャー / Data manager

CROマネジメントに加え、多様な臨床データの活用促進のため、データライフサイクルの管理を高品質・効果的に実施できる人財の拡充を行っています。

CROマネジメントおよびデータ流通プロセスの設計や管理、データマネジメント関連業務全般を担うことができる方を求めています。

CROのオーバーサイト

CROオーバーサイト手法の検討と実装

eSourceの活用検討と最適なデータマネジメントプロセスの策定

Why we are looking for Data manager

The role required of data managers in clinical development is changing significantly. In addition to CRO management for clinical studies, Chugai Pharmaceutical will expand the number of human resources who can conduct data lifecycle management with high quality and effectiveness to promote the use of various clinical data.

Responsibilities

Based on the background above, we are looking for someone who can handle CRO management, data distribution process design and management, and general data management related tasks.

Oversight of data management CROs in and out of Japan for our sponsored clinical studies and researches

Examination and implementation of effective CRO oversight method according to the purpose

Consideration of utilization of eSource in clinical studies / clinical research and development of optimal data management process

Management and examination of various data standards

Data engineering (Storage / extraction of data in data infrastructure for secondary use of data, formulation of storage process of new data types)

• From a medium-term perspective, you will be responsible for storing / exporting data to a data platform for secondary use using data engineering according to your aptitude, as well as data utilization.

Attractiveness of the Position

Contribute to deliver medicine to patients sufficiently, swiftly and constantly through fully accelerated clinical studies by promoting effective data management to enable making proper decision while accurately grasp the changes in environment regarding to regulation, technological innovation and others 応募資格／Qualifications ■求める経験

DM実務経験あるいはCRO企業におけるリーダー相当のDM実務経験

SOP）作成、ガイドライン新設および周知活動の実施

CROへ委託したデータマネジメント業務オーバーサイト

RBMの概念

https : / / www.transceleratebiopharmainc.com / assets / risk-based-monitoring-solutions /

DCTの各手法および留意点

https : / / www.jpma.or.jp / information / evaluation / results / allotment / gbkspa00000017ol-att / DS_202208_DCT_f01.pdf

TOEIC800点以上程度）

Must have

Experience as a data manager from quality control planning to completion of clinical trials

DM practical experience at a manufacturing company or DM practical experience equivalent to a leader at a CRO company

Nice-to-have (Experience)

Lead projects to improve operational efficiency and introduce data management / utilization systems

Creation of standard operating procedures (SOPs), establishment of new guidelines, and implementation of public awareness activities in the organization to the company you belonged

Oversight of data management operations outsourced to CROs

Response to applications such as document surveys

Participation in task forces of industry associations

Contribution as an author or co-author in papers and presentations at conferences / symposiums / workshops

Nice-to-have (Skill / Knowledge / Ability)

Concept of data integrity

Knowledge on the related regulations

Concept of Risk Based Monitoring

https : / / www.transceleratebiopharmainc.com / assets / risk-based-monitoring-solutions /

DCT methods and each point to consider

https : / / www.jpma.or.jp / information / evaluation / results / allotment / gbkspa00000017ol-att / DS_202208_DCT_f01.pdf

Project management skills required to implement operations

Data engineering experience (infrastructure construction, curation, visualization, lifecycle management)

Who fit us

Involve stakeholders to identify issues and derive solutions appropriately

Set challenging goals and commit to achieving them with a sense of ownership and responsibility to deliver results

Proactively gather information on the latest technology and industry trends, and propose feasible strategies and action plans for the future in line with the company's strategy

Able to redefine goals and your role as the situation changes

Always seeks efficiency and results in a short period of time

Must have (Qualifications)

Communication skill in English (written and spoken); equivalent to TOEIC score 800 or more 待遇／Salary & Benefits ■各種手当

OJT日常業務遂行の中でのスキル向上

OFF-JTと自己啓発

30,000円／月）

Full-Flextime system

To be decided in accordance with our criteria

The notification of working conditions will be made in an electronic file.

If you apply, please understand this point.