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Associate Director, Clinical Data Management
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$173,700 - $208,500 a year
Full-time
- 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 Associate Director of Clinical Data Management is an individual contributor and is responsible for planning, implementing, and managing Clinical Data Management (CDM) activities across trials and programs, including but not limited to database and technology selections, vendor management, data collection, and ensuring quality standards are maintained.
- Ensure projects are conducted in compliance with operating procedures, GCP, ICH, Good Clinical data management practices, FDA regulations, and CDISC and FDA submission standards.
- Lead internal data manager for assigned studies and programs overseeing all data management activities performed by CROs; ensuring major Clinical DM deliverables and milestones are met from study start-up to database lock.
- With a thorough understanding of the protocol, review and manage key Clinical DM study documents, such as DM plans, guidelines for CRF completion, data review, SAE reconciliation, Vendor Oversight, TMF plans, and data audits.
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