上海和记黄埔医药
上海 ·医疗卫生 ·100-499人
数据管理经理
25-26K·15薪
上海
3-5年
本科
全职
职位描述
KEY ACCOUNTABILITIES
Responsible for executing end to end clinical data management (CDM) activities pertaining to clinical trials, including but not limited to: perform data management activities in compliance with Hutchison Standard Operating Procedures (SOPs) and ICH-GCP guidelines, oversee the process and quality of data management work contracted to a CRO, perform data integrity review.
The Clinical Data Scientist is accountable to:
l Provides early input into protocol design, contracting process focused on data management issues;
l 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
l 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
l Leads the development of eCRFs, database and all the other DM activities for the study handled internally by interacting with other functional area representatives;
l Ensure the TMF maintenance of Data Management is on time with good quality.
l Continually evaluates data management processes and applications for improvements.
Complexity:
l Understand conceptual basis for data management conventions, standards and processes.
l Anticipates problems, issues, and delays, and proactively works to minimize the impact.
Specialised Knowledge:
l Clinical Data Management System experience (e.g., Clintrial, Oracle Clinical, Inform, RAVE) and understanding of database/programming concepts.
l Knowledge of the clinical development process.
l Knowledge of industry standards and practices, e.g. CDISC.
Minimum Requirements:
l Educated to at least Bachelor level in Medicine, Pharmacy, Biological Sciences, or health care related disciplines.
l At least 3-year data management experience in pharmaceutical company or Clin
Responsible for executing end to end clinical data management (CDM) activities pertaining to clinical trials, including but not limited to: perform data management activities in compliance with Hutchison Standard Operating Procedures (SOPs) and ICH-GCP guidelines, oversee the process and quality of data management work contracted to a CRO, perform data integrity review.
The Clinical Data Scientist is accountable to:
l Provides early input into protocol design, contracting process focused on data management issues;
l 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
l 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
l Leads the development of eCRFs, database and all the other DM activities for the study handled internally by interacting with other functional area representatives;
l Ensure the TMF maintenance of Data Management is on time with good quality.
l Continually evaluates data management processes and applications for improvements.
Complexity:
l Understand conceptual basis for data management conventions, standards and processes.
l Anticipates problems, issues, and delays, and proactively works to minimize the impact.
Specialised Knowledge:
l Clinical Data Management System experience (e.g., Clintrial, Oracle Clinical, Inform, RAVE) and understanding of database/programming concepts.
l Knowledge of the clinical development process.
l Knowledge of industry standards and practices, e.g. CDISC.
Minimum Requirements:
l Educated to at least Bachelor level in Medicine, Pharmacy, Biological Sciences, or health care related disciplines.
l At least 3-year data management experience in pharmaceutical company or Clin
公司介绍
和黄医药的目标是成为一家为中国和全球市场开发创新药物的领先的医药公司。我们诚邀有志人士加入我们的团队。我们致力于让每一名员工能够发挥才干，并提供互相协作的工作环境以回报您的才能和热情。如果您希望成为我们团队的一员，请将您的简历发送给我们
上海浦东新区和记黄埔医药(上海)有限公司1楼
面试经验
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