Clinical Data Manager
Responsible for creation of DMP (Data Management Plan) and Edit Checks Specifications, Edit Checks Testing and Validation for both Paper and EDC studies such as AGIIS (IVRS/IWRS), CAT, UAT and DTD Testing, Reports, Review and Validation. Data Cleaning/Discrepancy Management of paper-based and EDC projects according to the SOPs to ensure compliance with the study protocol. Support of the documentation, testing, implementation, validation, and utilization of systems used in Clinical Data Management activities.
- Recognized by Senior Department Managers for superior performance and requested by name to support other departments with tight deadlines.
- Received Award of Excellence for identifying critical discrepancies in the database that supported company's FDA submission for drug approval.
- Key member of a data quality improvement team that reduced data errors by 70%.
- Assigned by senior management to Project Initiation Group based on expertise in database design, report testing and database validation.