Candidate with academic CRO experience would also be fine, leading the study (3-4 studies). Understands data management and documentation process. Candidate who has worked on clinical trials as clinical data manager, CRF design and clinical data management plan, study maintenance. Works with clinical programmers, CRA, statistical programmers, biostatisticians and other clinical, DSPH, regulatory and project management staff to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting. Demonstrates a general understanding of each assigned protocol, critical tasks and milestones. Ensure completeness, correctness and consistency of routine clinical data and data structure. Assists in the implementation of routine clinical data management process with vendors including data entry, data quality checking, data transfer, reporting, backup, and recovery. Assists in the preparation of CRF/eCRF for data collection through the regulatory approval process. Assists in implementing routine clinical research projects. Reviews study protocol and assists site coordinators, investigators, and field clinical staff in collecting routine data to meet the protocol requirements in a timely manner. Identifies, tracks, and resolves routine queries. Utilizes routine reports to track study progress and ensures timeliness and quality expectations are met. The ability to problem solve and have people/project leadership skills. Knowledge of FDA regulations, support of needs for NDA and other regulatory submissions, and familiarity with web-based Electronic Data Capture (EDC) and clinical data management systems.
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