GDIT's Military Health team is hiring a Clinical Database Developer to support the Office of Regulated Activities (ORA) under the DoD (Dept. of Army) located at Ft. Detrick in Frederick, Maryland, to ensure the well being of U.S. citizens by providing services that help the government develop Food and Drug Administration regulated medical products for the Warfighter.
Requirements
- Hands on experience with InForm GTM
- Experience with EDC
- Experience with Central Designer and Oracle
- Experience providing technical support related to protocol-specific data management databases and end users
- Experience reviewing SOPs, work instructions, policies, manuals/user guides, and documents related to data collection and management activities and testing and validation documentation of data management systems
- Experience using the MRDC in-house CRDMS a plus
- Excellent written and oral communication skills
Responsibilities
- Be responsible as a performer or an oversight Clinical Database Developer across multiple projects for data management activities and deliverables in various phases of the clinical trial lifecycle
- Participation in the review of SOPs, work instructions, policies, manuals/user guides, and documents related to data collection and management activities and testing and validation documentation of data management systems
- Creation and maintenance of mock electronic case report forms (eCRFs) for electronic data collection method or CRFs for paper-based data collection method designed conforming to the required study data standards and the protocol-specific requirements and objectives
- Design, development, testing, validation, and maintenance of protocol-specific data management databases meeting and conforming to the approved mock eCRFs or approved database modification requests
- Participation in the creation and maintenance of Data Management Plans (DMPs) describing the processes and procedures governing the data management activities for producing data management deliverables
- Participation in the creation and maintenance of Data Validation Plans (DVPs) outlining quality control checks on CRF data that will be performed manually or programmatically within or externally from the protocol-specific data management databases
- Provide data management oversight support that the Clinical Database Developer is responsible for on data management activities conducted by data management vendors to ensure compliance with applicable regulations
Other
- Education: Bachelor’s Degree in Computer Science, or a related discipline, or the equivalent combination of education, professional training, or work experience
- Required Experience: 5 years of related clinical database development experience and must have experience providing clinical research data management oversight support
- US Citizenship Required
- Must be able to obtain a T3 security clearance
- Location: Frederick, MD (Hybrid), must reside within commuting distance
