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Remote Senior Clinical Data Operations Manager
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Full-time
Remote
- Ensures the DCC meets operational objectives for IDCRP’s study protocols in coordination with the Chief of Data Operations, Center Operations, Science Directorate, and Principal Investigators.
- Completes and oversees analysis of protocol documents to generate study database design specifications including CRF/eCRF design, visit schedule, edit checks, system notifications, query logic, user role setup, randomization triggers, supply triggers, and medical coding.
- Ensures, reviews, and quality controls against associated project protocol, NIAID requirements, CRF standards templates, Good Clinical Data Management Practices (GCDMP), and where applicable CDISC Clinical Data Acquisition Standards Harmonization (CDASH) standards.
- Certified Clinical Data Manager (CDM) certification preferred.
- Experience with the administration and utilization of electronic data capture (EDC) systems for collection of clinical research data; REDCap experience preferred but not required.
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