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.
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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 initiatives
PRIMARY RESPONSIBILITIES:
- Assist with Clinical Data Management (CDM) activities with clinical trial monitors
- Maintain 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. xhqgsiq
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.
Clinical Research Data Manager - NIH in bethesda at Unknown Company
This position is listed as contract and onsite.