a) Key working relationships / 主 要 工 作 关 系
- Internal contacts / 内 部 联 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 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