メディカル・バイオ - メディカルデータマネジメント

■ 職務内容 / Job Description

Responsible to coordinate the Clinical Data Management (CDM) deliverables on assigned clinical projects and may be an expert on CDM processes, standards and technologies, such as EDC and other tools (PV提供用 安全性差分レポートツール, etc.). Member of the Study Team (ST) and the main point of contact for the Data Management (DM) vendor. Responsible to ensure CDM deliverables follow standards and meet data quality. Maintains Business Continuity for CDM processes and standards including integrity of the clinical database for the relevant studies with ensuring AIR(always inspection readiness).
Typical Accountabilities


Coordinate the CDM deliverables on assigned projects depending on the relevant model and DM Vendor. Takes accountability and serves as the first line of contact at the study level.
Communicates and collaborates effectively with all study level team members. Primary point of contact for DM vendor and provides guidance and supervision to Lead DM/DM Team Lead working on the study (CRO or in-house).
Oversight of the day to day operational aspects of CDM for assigned studies; Responsible to identify risks and collaborate with the DM Vendor to mitigate the risk.
Provide input into CDM related activities associated with regulatory inspections/audits for assigned RIST project(s).
May provide input to the selection and use of software systems, devices and vendors from the CDM perspective.
Drive adherence to AZ CDM standards and processes for data quality and consistency of data capturing for assigned studies.
Maintain an awareness of the external and internal models in order to participate in change initiatives and continuous improvement activities related to CDM operating models.
Demonstrates willingness to take on ad hoc activities consistent with current or experience in support of CDM and Japan DO/R&D organization direction, such as contributing the data driven decision making.

■休日：完全週休二日制, 年末年始

■ 応募資格（経験、資格等）/ Qualification (Experience & Skill etc.)

＜必須 / Mandatory＞
Solid knowledge of CDM, Database and experience in the Biotech/Pharma/CRO industry Demonstrated current understanding of Good Clinical Data Management Practices (GCDMP) and relevant regulatory requirements
Demonstrated experience of clinical databases, different clinical data management systems and electronic data capture (EDC)
Demonstrate understanding and experience in query management process and reconciliation activities

＜歓迎 / Nice to have＞
Demonstrated knowledge of clinical and pharmaceutical drug development process
Demonstrated understanding of clinical data system design / development / validation and system interoperability.
Demonstrated ability to work effectively with external partners
Demonstrates professionalism, diplomacy, mutual respect and the ability to manage/value diversity and cultural differences and promote productivity through encouragement

【資格 / License】

＜必須 / Mandatory＞
Bachelor’s Degree

＜歓迎 / Nice to have＞
Certified Clinical Data Management

【能力 / Skill-set】

＜必須 / Mandatory＞
Good communication and interpersonal skills including effective problem solving
Ability to work independently without close supervision
Excellent written and verbal communication skills
Ability to work in a global team environment
Excellent organizational and analytical skills and high attention to detail
Excellent knowledge of spoken and written English

＜歓迎 / Nice to have＞
State of the art understanding of database structures, programming languages, data standards (CDISC) and practices as they apply to CRF design, database development, data handling and reporting

【語学 / Language】

＜必須 / Mandatory＞
日本語 Japanese：ネイティブ

英語 English：英語 English： Business English (Achieve common understanding at the context level with customers)

【その他 / Others】

＜必須 / Mandatory＞
Computer proficiency

＜歓迎 / Nice to have＞
Knowledge of SQL, VBA, Python/R software, BI tool(Spotfire, Power BI) , and RWD

■職種未経験者：不可