GDIT's Military Health team is hiring Data Manager to support the Office of Regulated Activities (ORA) under the DoD (Dept. of Army) located at Ft. Detrick in Frederick, Maryland.
The Office of Regulated Activities (ORA) is a multidisciplinary team of regulatory affairs, compliance, and clinical support professionals dedicated to supporting the USAMRDC mission of developing Food and Drug Administration regulated medical products for the Warfighter. The ORA provides full-service, oversight, and consultation for regulatory, clinical, non-clinical, manufacturing, data management, biostatistics, product technical, safety monitoring.
In this role, the Data Manager will:
Provide data management support according to the applicable regulations, guidance, and industry standards using a 21 CFR Part 11 compliant clinical data management system. This support will include at minimum the following activities:
Develop Data Management Plans specifying all data management activities that reflect Good Clinical Data Management Practices based on Good Clinical Data Management Practices (GCDMP), Good Clinical Practices, and ICH guidelines.
Perform Case Report Development activities
Document 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.
Develop technical support plans that include end user support and the development, modification, maintenance, testing, and validation of the protocol-specific Electronic Data Capture (EDC) database throughout the life of the trial.
Develop database training support plans.
Perform data quality checks
Document data reconciliation through a written report.
Participate in medical coding activities
Perform database closure activities
Participate on project meetings
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 data management experience.
Excellent written and oral communication skills.
Must be U.S. citizen and be able to obtain a T1.
Experience developing Data Management Plans including Good Data Management Practices based on good Clinical Data Management Practices, Good Clinical Practices, and ICH guidelines.
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 does not have a vaccination mandate applicable to all employees. To protect the health and safety of its employees and to comply with customer requirements, however, GDIT may require employees in certain positions to be fully vaccinated against COVID-19. Vaccination requirements will depend on the status of the federal contractor mandate and customer site requirements.
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.