Job Description:

Manager, Data ManagementRESPONSIBILITIES• Manage and supervise a team of Clinical Data Managers (CDMs)Oversee each project assigned to the teamQC each deliverable prior to sending to internal or external clientsPrepare and present individual performance reviewsProvide mentorship to DM staff and suggestimplement solutions for complex issuesAssist staff with interactions with sponsors and managing vendorsKeep supervisor updated on study progress and staff management through routine meetingsMaintain a positive, progressive, and proactive management style and communication• Develop and update data management SOPs and training manuals• Conduct data management training as well as study specific training for the CDM and study teams• Provide input from the data management perspective regarding the design of clinical trial protocols• Oversee, develop and maintain study-specific documentation, including Data Management Plans, eCRF specifications, CRF Completion Guidelines, Data Validation Guidelines, Data Transfer Specifications, Coding Guidelines, Post Production Database Change Control Documentation, Database Audit and Lock ProceduresOversee and participate in the process of data review and query generation proceduresOversee and participate in the coding of medical termsOverseedefineperform SAE reconciliation processes• Work with DM leads and DB programmers to design (e)CRFs and edit checks in EDC system• Ensure proper completion of UAT of EDC system and modules• Oversee DM lead to ensure efficiency and quality of electronic data receipt, integration, and reconciliationEDUCATION• Minimum BS in a scientific or health related field or equivalentEXPERIENCE• Minimum of 10 years of experience in Clinical Data Management• A minimum of 2 years supervisory experience is required