高级临床数据管理员

? Clinical Research Team

? Quality Assurance / Quality Control

? Local drug supply chain

? R&D, GMA, Global ESRO, etc

? Procurement

? Regulatory Affairs

- External contacts with organizations outside / 外 界 联 系

? Principal Investigator/Co-Investigators

? CRO/SMO

? Any other vendors if related to function scope and responsibility

(b) Job requirements /工 作 要 求

? Results Driven Behavior

? Self-motivation and adaptability

? History of successful managerial experience on project management

? Ability to form strong alliances with marketing teams and among own team members

(c) Academic / Professional qualification / 学 历 / 专 业 资 格

Bachelor or higher degree in Science, Medical or Pharmaceutical Background

(d) Technical / skill training / 技 术 / 技 能 训 练

? Data Management Experience

? Knowledge of GCP, SOPs and drug development and regulations

? Comprehensive knowledge of CDASH/SDTM/ADaM CDISC standards and metadata management Skills for CRF/eCRF design

? Cross-function experience in drug development, particularly CRF/eCRF design and DM

? Ability to see cross-project dependencies and act to resolve issues

? Good presentation and communication skills across different business areas

? Effective meeting and time management

? Negotiation skills

(e) Working experience

I) Essential 必 需

? At least 5 relevant working experience in drug development or medical affair in a pharmaceutical company or CRO setting.

? Disease Area expertise in one or more therapy areas

II) Desirable 理 想

? Knowledge of observational studies and/or real world data

- III) Language ability / 语 言 能 力

? Excellent written and verbal communication skills in English and Chinese

- IV) Computer literacy / 电 脑 知 识

? PC/Windows application