Clinical Data Management
1 month ago
Work with DB programmers to design (e)CRFs and edit checks in EDC system for complex studies
Lead, coordinate, and perform User Acceptance Testing (UAT) tasks for complex studies and modules
Ensure proper completion of QC and UAT of EDC tools and modules, including database testing, data export testing, and testing of custom programming
Coordinate with Sponsor and Vendors to ensure efficiency and quality of electronic data receipt, integration, and reconciliation
Design "smart " listings and study–specific processes for effective data review, query issue and resolution
Perform coding of adverse events, medical conditions and medications.
Perform SAE reconciliation
Lead and perform pre–lock and data lock tasks
Prepare training materials and user guides for EDC data collection tools, deliver user training
Design, generate, and review status metric reports, identifying and communication trends as needed
Provide input to cross–functional study timelines and resource requirements to ensure timely completion of project milestones for complex studies
Provide study specific training for team members and end users, as appropriate
Lead large and complex projects
Lead client and team meetings as required
Interact with sponsors and manage vendors for complex studies
Present at sales and marketing meetings for prospective clients
Develop SOPs and manuals
Education & Experience:
Minimum 9 years of experience in Clinical Data Management
Minimum BS in a scientific or health related field or equivalent
Previous experience working for a CRO required
Knowledge of medical terminology and pharmaceutical notation
Expertise with EDC systems, such as Medidata Rave, InForm, Medrio
Excellent organizational and time management skills
Strong collaboration and leadership skills
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