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 develop and maintain clinical databases for regulated medical products for the Warfighter.
Requirements
- Hands on experience with InForm GTM
- Experience with EDC
- 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
- Clinical Data, Data Management, Data Standards
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
- Preparation and setup of database instances for development testing, User Acceptance Testing (UAT), training, and production
- Conduct of development testing and UAT
- Participation in the creation and maintenance of request and approval documentation for protocol-specific data management database production releases and locking/unlocking
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
- Excellent written and oral communication skills
