GDIT in seeking a ClinicalData Specialist in support of the Malaria Department for the Naval Medical Research Center Clinical Trials Center (NMRC CTC) located at Walter Reed National Military Medical Center (WRNMMC) in Bethesda, Maryland. The NMRC CTC conducts clinical trials of candidate vaccines designed to protect military against infectious diseases, such as malaria. GDIT provides scientific, technical and programmatic support services to the Malaria Department.
Specific tasks include:
Work with sponsor’s database developer for study trial electronic database creation and maintenance
Work with sponsor’s medical coder for study (adverse event, medical history, and medications) database queries and resolution
Work with study principal investigator and biostatistician in preparation of tables, listings, figures for final study reports and manuscripts
Coordinate with sponsor’s oversight data management designee for completion, update, and finalization of data management deliverables
Develop and coordinate review and approval of the study data management plan and supporting appendices, case report forms, database design specifications, and edit check list
Perform and provide documentation of study database testing and validation
Develop and provide end user guidelines, training, and end user technical support
Perform data discrepancy management activities
Create ad hoc study data reports and listings using Oracle Cognos software (Inform reporting)
Coordinate raw data extraction for data analysis by the biostatistician
Perform final study data quality assessment and related activities for data lock and study closure
Participate in teleconferences/meetings with the sponsor and other NMRC representatives
Perform other duties as needed in support of ongoing clinical trials:
Review subject charts for clarity, completeness and accuracy of collected data
Labeling and shipping of blood specimens
2+ years of experience within clinical research
Demonstrates strong organization skills
Well versed in the use of Microsoft Office Suite
Experience working within a dynamic team
Must be a US citizen with the ability to obtain a favorable NACLC T3 security investigation
Experience analyzing data derived from clinical trials
Experience using analytical software
Experience with Oracle Cognos software
This position requires being fully vaccinated against COVID-19 by December 8, 2021 or the start date, if after December 8.
We are GDIT. The people supporting some of the most complex government, defense, and intelligence projects across the country. We deliver. Bringing the expertise needed to understand and advance critical missions. We transform. Shifting the ways clients invest in, integrate, and innovate technology solutions. We ensure today is safe and tomorrow is smarter. We are there. On the ground, beside our clients, in the lab, and everywhere in between. Offering the technology transformations, strategy, and mission services needed to get the job done.
GDIT is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other protected class.