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Sr. Director, Clinical Data Management
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- The company’s platform combines the latest advancements in visualization of molecular interactions, computational chemistry, and data integration to design orally available, superior small molecule medicines that overcome current limitations of biologic and peptide drugs.
- The Sr. Director, Clinical Data Management (CDM) will be responsible for the operational and strategic aspects of data management across the organization, including data governance, data quality, and data strategy.
- Ensure projects are conducted in compliance with operating procedures, GCP, ICH, Good Clinical data management practices, FDA regulations, and CDISC and FDA submission standards
- Review and approve data transfer plan for any external data that is imported into EDC (e.g., central lab and biomarker data).
- Manages and oversees reconciliation between EDC and non-EDC database, such as, SAE, Lab, and biomarker.
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