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.
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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)