Sr Clin Data Assoc

1 month ago


Remote, India Thermo Fisher Scientific Full time

Job Description

Summarized Purpose: 
Performs all aspects of the data cleaning process, with minimal supervision, in accordance with GCP and SOPs/WPDs in order to assess the safety and efficacy of investigational products and/or medical devices.

Essential Functions:
  • Supports the setup of study activities such as database design, testing of data entry screens, and Data Validation Manual (DVM) creation, as required.
  • Reviews data listings for accuracy and consistency of data. 
  • Acts as point person and subject matter expert for specialized study-specific  processes.
  • Generates, tracks and resolves data clarifications and queries and makes changes to the clinical database as required. 
  • Contributes to the improvement of data management processes on a global level.
  • Produces project-specific status reports for management and/or clients on a regular basis. 
  • Provides training and work direction to junior staff as required.
Education and Experience: Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3 - 7 years' experience)
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