Clinical Research

• Manage all aspects of clinical trial data management from study start-up through post-database lock for assigned projects
• Serve as primary Data Management contact and Lead Data Manager for assigned clinical projects/programs
• Oversee data entry processes, including guidelines, training, quality, resourcing, and quality control
• Assess and manage timelines, deadlines, and resource needs
• Develop CRF specifications from clinical study protocols and coordinate stakeholder review
• Assist with clinical database builds and conduct database build UAT
• Maintain quality-controlled database build and data management documentation, including Trial Master File completeness
• Specify and oversee edit checks and manual data review specifications
• Train clinical research personnel and data management project team members
• Review and query clinical trial data according to the Data Management Plan
• Perform line-listing data review and patient/study-level status and metric reporting
• Perform medical coding and coordinate SAE/AE reconciliation
• Liaise with third-party data and EDC vendors regarding timelines and deliverables
• Identify and troubleshoot operational problems using metrics, audit reports, and stakeholder input
• Participate in SOP/process documentation development and maintenance
• Communicate with study sponsors, vendors, and project teams regarding data and database issues
• Provide leadership for cross-functional and organization-wide initiatives
• Participate in meetings, presentations, proposals, project estimates, software demonstrations, and trainings
• May assist with SAS programming and quality control of SAS programs
• May require some travel
• Perform other duties as assigned

Explore Senior Clinical Data Manager at Precision For Medicine. Review requirements and application details.

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