Data Manager
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When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. (a) Key working relationships / 主 要 工 作 关 系 - Internal contacts within AZ / 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 AZ / 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, AZ 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 ( Internal , External) - Effective meeting and time management - Negotiation skills (e) Working experience (No. of years / 年 资, Job function / 工 作 功 能, Business types / 业 务 种 类 ) 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 - V) Others / 其 他
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