Data Manager/Sr. Manager 部门:Clinical Development  工作类型:Full time, Employee
工作地点:Shanghai, China
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Responsibilities:


  • Performs tasks related to all aspects of the clinical trial data management process from study start up to database lock.
  • Design or review CRF and clinical database structures for data acquisition and data entry.
  • Create or review DRP, DMP and CRF completion instructions, identifies and resolves data flow process issues in collaboration with the project team.
  • Communicates with vendors to define required file format and content specifications for electronic files and establishes schedule and process for data transfers.
  • Liaises with third-party vendors such as central laboratories in a project-manager capacity.
  • Provide training to data coordinators.
  • Follows up on query responses and errors identified in data cleaning.
  • Monitors timelines to ensure data management-related deadlines are met.
  • Development of data validation specifications, test data creation & UAT.
  • Create or review CRF Completion Guidelines (CCG), SAE reconciliation Guidelines, etc.
  • Assist data validation and cleaning.
  • Assist in review of raw data or patient profiles through data listing and generating queries.
  • Support site monitoring personnel to retrieve missing data as required.


Qualification:


  • BS, MS, MD or PhD in biology, chemistry, nursing or medicine with at least 3 years of clinical data management experience.
  • Fluent in written and verbal English
  • Title and compensation commensurate with qualifications and experienceTitle and compensation commensurate with qualifications and experience.
  • Proactive and organized with exceptional follow-up.
  • Anticipate/ identify problems and takes appropriate action to correct.
  • High degree of accuracy with attention to details.
  • Willing and able to learn quickly in a fast-paced environment.
  • Excellent team player.