General Dynamics Information Technology – Federal Civilian Division is looking for a Clinical Database Developer to join our team to support the Department of Army. This position is based in the Ft. Detrick and Frederick, Maryland.
In this role, the Clinical Database Developer will:
Develop Code of Federal Regulations (CFR) questionnaire forms to capture the data required by the clinical protocol, that meets FDA submission requirements and conforms to Clinical Data Interchange Standards Consortium (CDISC)/ Clinical Data Acquisition Standard Harmonization (CDASH) standards and Study Data Tabulation Model (SDTM) controlled terminology.
Develop and maintain study-specific database, including CDASH annotated CRFs, that eflect the raw data extracted from the Clinical Data Management System and prior to the transformation into the Study Data Tabulation Plan (SDTM) datasets.
Develop database specifications describing all study-specific design, testing, and validation requirements, following CDISC/CDASH standards and SDTM Controlled Terminology.
Perform database testing and validation that includes a plan describing the User Acceptance Testing and validation processes/procedures of the study-specific database, testing scripts/documents, and validation documentation.
Create data listings and reports (e.g., metrics) that pertain to data management activities during study conduct.
Provide final raw data in Statistical Analysis Software (SAS) format compliant with CDASH and applicable CDISC standards prior to the transformation to SDTM datasets.
Collect and validate laboratory data in an electronic and analyzable format and in compliance with CDISC.
Collect and manage data according to the applicable FDA regulations, FDA guidance, ICH, CDISC/CDASH Standards, and Good Clinical Data Management Practices
Participate in special projects as required.
Bachelor’s Degree in Computer Science, or a related discipline, or the equivalent combination of education, professional training, or work experience.
5 years of related clinical database development experience.
Excellent written and oral communication skills.
Must be U.S. citizen and be able to obtain a T3.
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.