Requirements
Responsible for planning, execution, and delivery of Clinical Data Management projects on schedule and within budget, and within PPC and/or sponsor Standard Operating Procedures (SOPs).
Responsibility
Collaborate with respective project sponsor and stakeholders to develop effective project plans to include scope, goals, deliverables, required resources, risks, issues and milestone timing.
Develop and implement project plans for relevant Data Management projects.
Serve as Data Management Lead on selected projects
Create project specific Data Management Plans (DMPs)
Preparations of edit check specifications for a specific project, Data entry guidelines preparation, Case Report Form design and associated specification under the support of CDAs.
Assist with and/or oversee the creation of test data for entry screens and edit checks
Serve as primary contact for DM with all relevant parties including but not limited to Clinical Operations and Sponsor, informing stakeholders if there is a need to deviate from project scope or plan
Participate/attend Sponsor requested meetings as required
Participate in and/or contribute to Sponsor and/or Regulatory audits/inspections
Perform other duties as required by the Department.
qualifications and experience
BSc degree in biological science or a related discipline in the science/healthcare field or equivalent education
Minimum 7 years of experience including proven ability to lead data management activities
Effective communication skills
Ability to drive and oversee a cross-functional team via effective delegation and team workload assignment
职能类别: 临床数据分析员 医药技术研发管理人员
关键字: DM Data Management 临床数据管理
联系方式
上班地址:新天地中海国际中心(地铁1,9、10、13号线)
Get email alerts for the latest"Data Management Leader(DML) jobs in Shanghai"