Job Overview
Program Management and Technology Services, Inc. (PMTS) is seeking multiple Database Managers to support the Defense Health Agency (DHA) Research and Development MRDC Office of Regulated Activities (ORA) at Fort Detrick, MD. This is a contingent position pending award of a federal GSA MAS task order with a target start date of August 1, 2026.
The Database Manager oversees the administration, design, and operational integrity of clinical trial and regulatory information databases supporting the ORA program. This role provides technical leadership over Electronic Data Capture (EDC) systems, Clinical Trial Management Systems (CTMS), and related data platforms, ensuring that clinical data is captured, validated, and maintained in compliance with 21 CFR Part 11, GCP, and CDISC standards. The Database Manager supervises a team of database administrators and coordinates closely with the Clinical Database Developer, Statistical Programmers, and Data Management staff.
Responsibilities
- Manage day-to-day operations of clinical trial databases across the ORA portfolio, ensuring data integrity, availability, and 21 CFR Part 11 compliance
- Supervise and mentor a team of database administrators; assign work, review deliverables, provide technical guidance, and support professional development
- Design, implement, and maintain database schemas, user access controls, and system administration functions for enterprise clinical data platforms
- Coordinate database releases, database locks, and unblinding activities in accordance with study protocols and Data Management Plans
- Oversee edit check programming, query management, data reconciliation, and data quality assessment activities
- Support integration of external data sources (safety data, laboratory data, PK/PD data, ePRO data) into clinical trial databases
- Ensure system administration and management functions comply with FDA electronic records requirements and applicable ORA standards
- Participate in Data Management Plan development, CRF design review, and database specification review
- Support inspection readiness activities including FDA BIMO inspections and data integrity reviews
- Coordinate with the Clinical Database Developer on new database builds, protocol amendments, and system upgrades
- Maintain technical documentation including database specifications, validation documentation, and standard operating procedures
Required Qualifications
- Bachelor's degree in Computer Science, Information Systems, Life Sciences, or a related field required
- Minimum 6 years of clinical database administration experience with at least 2 years of supervisory or team lead experience
- Demonstrated expertise administering enterprise database platforms including SQL Server, Oracle RDBMS, and Windows Server environments
- Hands-on experience with clinical EDC systems (Medidata Rave, Oracle Clinical, Veeva Vault CDMS, or equivalent)
- Working knowledge of 21 CFR Part 11 electronic records requirements, GCP, and CDISC data standards
- Strong SQL, database design, and system administration skills
- Excellent leadership, communication, and problem-solving abilities
- U.S. citizenship required; ability to obtain and maintain a T1/HSPD-12 Public Trust investigation
Preferred Qualifications
- Master's degree in Computer Science, Data Science, or a related field
- Certified Clinical Data Manager (CCDM) credential from SCDM
- Prior experience supporting DoD, DHA, USAMRDC, WRAIR, or federal clinical research programs
- Experience with CDISC SDTM, ADaM, and Define-XML standards
- Familiarity with BMC Remedy Action Request System, ITIL, or federal IT service management frameworks
- AWS, Azure, or federal cloud environment experience
Pay: $92,000.00 - $125,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Work Location: In person
