Roles & Responsibilities :
- 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 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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