Address
Form of workWorks collaboratively with Clinical Programmers, CRA, Statistical Programmers, Biostatisticians and other Clinical, DSPH, Regulatory and Project Management staffs to meet project deliverables and timelines for non-routine Clinical Data acquisition, quality checking and reporting. Ensures completeness, correctness and consistency of Clinical Data and data structure. May lead in the design and implementation of Clinical Data management process with vendors including data entry, data quality checking, data transfer, reporting, backup, and recovery.
Leads the design of CRF/eCRF for sound and thorough data collection through the regulatory approval process. Reviews study protocols and assist in the planning and implementation of the data management portions of clinical research projects. Interact with site coordinators, investigators, and field clinical staff in collecting data and resolving queries to meet the protocol requirements in a timely manner.
Utilizes reports to track study progress and ensure timeliness and quality expectations are met.Excellent verbal and written communication skills and interpersonal skills are required. The ability to problem solve and have people/project leadership skills.General knowledge of FDA regulations and with web-based Electronic Data Capture (EDC), Clinical Data management systems and industry wide thesauri, such as MedDRA is also required.
