- 无工作经验
- 招1人
- 11-27 发布
职位描述
职位描述: KEY ACCOUNTABILITIESResponsible for executing end to end clinical data management (CDM) activities pertaining to clinical trials, including but not limited to: Oversee the process and quality of data management work contracted to a CRO, perform data integrity review. Develop data management tool and system, perform data management activities, in compliance with Hutchison Standard Operating Procedures (SOPs) and ICH-GCP guidelines.The Clinical Data Scientist is accountable to:?Provides early strategic input into protocol design, contracting process focused on data management issues;?Oversee the process and quality of data management work contracted out to a CRO or research collaborator. Be responsible for the oversight of all data review and cleaning activities involving close interaction with project clinical research professionals?Proactively communicates with project team to share project status, risk assessment and outstanding item resolution status. Ensures compliance to standard key performance indicators according to process?Leads the development of eCRFs, database and all the other DM activities for the study handled internally by interacting with other functional area representatives;?Ensure the TMF maintenance of Data Management is on time with good quality.?Continually evaluates data management processes and applications for improvements. Lead the development and implementation of new applications and procedures. Maintains knowledge of current regulations and technologies related to the data management function.Complexity:?Anticipates problems, issues, and delays, and proactively works to minimize the impact.?Understanding of the conceptual basis for data management conventions, standards and processes.Ability to develop solutions to complex problems.?Uses rigorous, objective logic and methods to solve difficult problems with effective solutions.?Ability to negotiate and strategically influence stakeholdersSpecialised Knowledge:?Clinical Data Management System experience (e.g., Clintrial, Oracle Clinical, Inform, RAVE) and understanding of database/programming concepts. Expert in the use of Data Management applications and database/file structures?Knowledge of the clinical development process. Good understanding of the role of data management, biostatistics and statistical programming in the drug development process.?Ability to apply advanced principles, theories and concepts for CDM as a whole.?Knowledge of industry standards and practices, e.g. CDISC.Minimum Requirements:?Educated to at least Bachelor level in Medicine, Pharmacy, Biological Sciences, or health care related disciplines.?At least 3-year data management experience in a multinational pharmaceutical company or Clinical Research Organization (CRO)?Fluent oral and written English skills?Self-motivated, excellent in work planning and time managementPreferred Requirements:?Knowledge of relevant aspects of therapeutic areas, especially knowledge of oncology and immunology?Able to work under pressure and in a changing environment with flexibility?Good communication skills with the ability to communicate with both the technical and business areas. 职能类别: 临床数据分析员 临床研究员
联系方式
张江高科技园区哈雷路917弄4号楼
公司信息
和记黄埔医药(上海)有限公司(和记黄埔医药)是一家由香港和记黄埔有限公司(和黄)全资投资的医药研发企业。和黄成立于十九世纪,是香港著名的跨国公司,现已成为全球500强企业之一。 和记黄埔医药2002年9月成立,位于上海张江高科技园区,公司致力于为全球市场开发创新药物。和记黄埔医药拥有一套完整的药物研发体系和一流的研发平台。公司的高级管理层主要来自美国的世界知名医药及生物科技公司,拥有丰富的新药研发管理经验。在短短几年中,公司在癌症和自身免疫性疾病领域,开发了多个临床前和进入临床研究阶段的创新药物。公司现有两个创新药物在美国、欧洲和澳大利亚进行临床实验,同时还有多个项目正在中国处于临床前及临床开发阶段。 和记黄埔医药通过将世界一流的研发经验、技术平台与中国的资源相结合, 开发出高质量的临床候选药物,并将新药项目快速推入早期临床开发。和记黄埔医药通过多种研发途径来达到最优的产出,包括来自合成小分子化合物、半合成天然产物以及植物药的创新药物。成立至今,和记黄埔医药已与世界知名医药公司在多种疾病领域内建立了广泛的战略合作。 和记黄埔医药为员工提供有竞争力的薪资福利、以人为本的工作环境和良好的职业发展机会。我们期待敢于挑战的优秀人才加入我们的团队。
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