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Sr Clin Data Assoc
Pharmaceutical Product Development (PPD)
Remote, India
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)
Job posted: 2024-02-01