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a) Key working relationships / 主 要 工 作 關(guān) 系
- Internal contacts / 內(nèi) 部 聯(lián) 系
? 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 聯(lián) 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 / 學(xué) 歷 / 專 業(yè) 資 格
Bachelor or higher degree in Science, Medical or Pharmaceutical Background
(d) Technical / skill training / 技 術(shù) / 技 能 訓(xùn) 練
? 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 / 語 言 能 力
? Excellent written and verbal communication skills in English and Chinese
- IV) Computer literacy / 電 腦 知 識
? PC/Windows application