Clinical Database Developer; Clinical Research

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 rick 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.

This is a hybrid position and will report onsite 2 days a week rick in Frederick, Maryland. Must reside within commuting distance.

• Be responsible as a performer or an oversight Clinical Database Developer across multiple projects for the following, but are not limited to, data management activities and deliverables in various phases of the clinical trial lifecycle (e.g., pre-study start, study start up, study conduct, and study closure):
• 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.
• Participation in the protocol review (from the initial drafts to finalization and subsequent amendments).
• 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.
• 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.
• 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 (post-go live), required study data standards, the protocol-specific requirements and objectives, applicable regulations and guidelines, and the respective systems capabilities and requirements.
• Design, creation, and maintenance of protocol-specific data management database design specifications defining data definitions and structure conforming to the applicable study data standards, visit and form workflow and dynamic generation, warning flag and query generation edit checks, and monitoring/tracking status parameter settings.
• Preparation and setup of database instances for development testing, User Acceptance Testing (UAT), training, and production.
• Creation and maintenance of protocol-specific data management database testing and validation documentation.
• Testing and Validation Plan describing the testing, validation, and documentation processes and procedures in the development testing phase, internal data management team testing phase, and User Acceptance Testing (UAT) phase.
• Supporting testing and validation documentation (e.g., test cases/scripts, testing results/findings logs/summary, query listing, data outputs, data extractions, data dictionary, annotated CRF).
• Creation and maintenance of request, approval, and testing and validation documentation for all protocol-specific data management database modifications implemented after the initial release for 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.
• Creation and maintenance of technical support plans describing the scope and level of support for end users on…