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
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
- Knowledge of applicable regulations (e.g., 21 CFR Part 11, 21 CFR 312.62(c), 812.140(d), ISO 14155), Good Clinical Data Management Practices (GCDMP), Good Clinical Practices (GCP), and ICH guidelines
- Knowledge of study data standards (e.g., CDASH, Study Data Tabulation Model (SDTM), Study Data Tabulation Model Implementation Guide for Medical Devices (SDTMIG-MD), Controlled Terminology, Therapeutic Area)
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
- 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
- Design, development, testing, validation, and maintenance of protocol-specific data management databases meeting and conforming to the approved mock eCRFs (or similar documentation listing the agreed data point collection) or approved database modification requests
- 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
- Participation in defining specifications and generation of reporting and data exports/outputs (e.g., metrics reports, SAS datasets, customized data listings in Excel format)
Other
- US Citizenship Required
- Must be able to obtain a T3 security clearance
- Must reside within commuting distance to Ft. Detrick in Frederick, Maryland
- 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 and must have experience providing clinical research data management oversight support
