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Clinical Database Developer
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Full-time
- GDIT's Military Health team is hiring Clinical Database Developer to support the Office of Regulated Activities (ORA) under the DoD (Dept. of Army) located at Ft. Detrick in Frederick, Maryland.
- Participation in the creation and maintenance of the essential data management documents, including but are not limited to, CRF Completion Instructions, Data Entry Guidelines, Medical Coding Conventions, Self-Evident Corrections, Data Handling Conventions, Data Clarification Forms (DCFs), and Data Management Deliverable Checklist and Tracking.
- Participation in defining system integration requirements and specifications, testing and validation implementation, and integrated data handling and reconciliation plans (e.g., Interactive Response Technologies (IRT), Electronic Clinical Outcome Assessment (eCOA
- Review of external Data Transfer Plans/Agreements and the supporting transfer specifications, testing and validation documentation (e.g., Central Laboratory, eCOA, Pharmacokinetics (PK
- Participation in the protocol-specific data management database closure, project closure, and study Trial Master File archiving of all data management deliverables (e.g., subject CRFs, final query reports, final audit trial reports, interim and final raw data in Clinical Data Acquisition Standards Harmonization (CDASH), data from external sources/transfers, essential data management documents).
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