■ 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