Clinical Research Data Manager - NIH

Kelly Government Solutions is a strategic supplier and business partner to the federal government and its key suppliers. The National Institutes of Health is seeking a Data Manager supporting clinical research. This is a long-term, full-time, contract position based in Bethesda, MD. This position offers a competitive benefits package.This is a long-term contract position which offers:- Competitive compensation and comprehensive benefit package- Optional health, vision, and dental plans- Paid leave, paid federal holidays, and 401K plan.- Access to NIH’s unparalleled resources and niche scientific initiativesPRIMARY RESPONSIBILITIES:Assist with Clinical Data Management (CDM) activities with clinical trial monitorsMaintain study databases and conducts basic analysis.Design and develop databases to clinical trial data specifications, eCRF vs paper CRF, user requirements, edit rules, query logic, and data validations.Data management resource for clinical team for preparation of data collection for clinical study reports, regulatory submissions, and assist with other clinical data submissions.Ensure clinical data within electronic data capture (EDC) is in quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and as a final locked database.Assist researchers collect, distribute and file regulatory documents.Assist researchers prepare submissions to regulatory bodies in support of clinical trials.Assist with Clinical Data Management (CDM) activities with clinical trial monitors 5 Provides technical support to researchers and the clinic.Generate Data and Safety Monitoring Board (DSMB) reports, Safety Review and Communication Plan (SRCP) reports, and other custom data reports as requested by the PI.Serve as data management resource for clinical team for preparation of data collection for clinical study reports, regulatory submissions, and assist with other clinical data submissions.REQUIREMENTS:Minimum bachelor’s degree in a Science related field with at least six (6) years of data management experience with CRF and DFdiscover databases.