Clinical Database Developer; Clinical Research

Job Overview

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 rick in Frederick, Maryland. The ORA is a multidisciplinary team of regulatory affairs, compliance, and clinical support professionals dedicated to supporting the USAMRDC mission of developing FDA‑regulated medical products for the Warfighter.

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

• Serve as a performer or oversight Clinical Database Developer across multiple projects, managing data‑management activities in various phases of the clinical trial lifecycle.
• Review SOPs, work instructions, policies, manuals/user guides, and related documents for data collection and management, as well as testing and validation documentation of data‑management systems.
• Participate in protocol review from initial drafts to finalization and subsequent amendments.
• Create and maintain mock electronic case report forms (eCRFs) or paper‑based CRFs that meet required study data standards and protocol specifications.
• Develop and maintain Data Management Plans (DMPs) and Data Validation Plans (DVPs) describing processes for data‑management deliverables and quality control checks.
• Design, develop, test, validate, and maintain protocol‑specific data‑management databases, ensuring compliance with data standards, regulations, and system requirements.
• Prepare and set up database instances for development testing, UAT, training, and production.
• Document testing and validation activities, including test plans, test cases/scripts, results, queries, data outputs, and data dictionaries.
• Create and maintain technical support and training plans for end users, and conduct trainings on data entry, source verification, query management, reporting, and medical coding.
• Maintain essential data‑management documents such as CRF Completion Instructions, Data Entry Guidelines, Medical Coding Conventions, DCFs, and the Data Management Deliverable Checklist.
• Define specifications for reporting and data exports (e.g., metrics reports, SAS datasets, Excel listings) and oversee system integration requirements, including IRT and eCOA integration.
• Review external Data Transfer Plans/Agreements and related documentation for laboratories, eCOA, and pharmacokinetics.
• Support protocol‑specific database closure, project closure, and study Trial Master File archiving of all deliverables.
• Identify and register project risks related to data‑management processes and deliverables.
• Provide oversight support for vendor‑conducted data‑management activities to ensure compliance with 21 CFR Part 11, ICH guidelines, and GCP.
• Collaborate with the ORA data‑management team on timelines and deliverables, and with MRDC’s technical team on troubleshooting and system maintenance.
• Log, track, and maintain progress and resolution history for technical issues across all supported projects.
• Provide end‑user technical support related to protocol‑specific databases using the MRDC in‑house CRDMS.
• Work within an interdisciplinary team governing various regulatory pathways (IDE, IND, NDA, BLA, EUA) across multiple disease areas.

• Education:
  
  Bachelor’s Degree in Computer Science or a related discipline, or equivalent combination of education, professional training, or work experience.
• Required Experience:
  
  5 years of related clinical database development experience and experience providing clinical research data‑management oversight support.
• Hands‑on experience with InForm GTM, EDC, and the MRDC in‑house CRDMS.
• Experience providing technical support to protocol‑specific databases and end users.
• Experience reviewing SOPs, work instructions, policies, manuals & user guides, and data‑collection and management documentation.
• Excellent written and oral communication skills.
• Location:
  
  Frederick, MD (Hybrid). Must reside within commuting distance of Ft. Detrick.
• Security Clearance:
  Must be able to obtain a T3.
• US Citizenship Required.

• 401(k) with company match
• Comprehensive health and wellness packages
• Internal mobility team dedicated to career growth
• Paid education and certifications
• Cutting‑edge technology
• Paid vacation and holidays

Equal Opportunity Employer / Individuals with Disabilities / Protected Veterans

Salary range: $82,450 - $111,550 (based on experience, location, and contractual requirements). This is not guaranteed and may fall outside this range.

Scheduled Weekly

Hours:

40

Travel Required:

None
Telecommuting Options:
Hybrid

Work Location:

USA – MD, Fort Detrick

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