Clinical Data Management - Katalyst Healthcares & Life Sciences

• 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