What are the responsibilities and job description for the Development Security Operations Engineer position at CEDAR HEALTH RESEARCH LLC?
Position Summary
The Development Security Operations Engineer (DSOE) is responsible for embedding security, privacy, and compliance controls into clinical trial systems, applications, and data platforms across the software development lifecycle (SDLC). This role ensures secure handling of clinical research data while supporting regulated environments subject to GxP, HIPAA, FDA, and global clinical trial regulations.
Key Responsibilities
- Integrate security and compliance controls into CI/CD pipelines supporting clinical trial systems and platforms
- Design, implement, and maintain secure infrastructure for clinical data applications (EDC, CTMS, eTMF, RTSM, data lakes)
- Implement security testing and validation activities aligned with GxP and CSV (Computer System Validation) requirements
- Conduct vulnerability assessments, code scanning (SAST/DAST/SCA), and risk assessments for regulated systems
- Automate security monitoring, alerting, and audit logging for clinical trial environments
- Partner with Clinical Operations, IT, Quality, and Regulatory teams to ensure inspection readiness
- Support data privacy and protection requirements for patient and investigator data (HIPAA, GDPR)
- Maintain documentation, SOPs, and evidence required for audits and regulatory inspections
- Lead incident response activities involving clinical trial systems and protected health information
- Promote DevSecOps best practices while balancing agility with regulatory compliance
- Bachelor’s degree in Computer Science, Information Security, or related field (or equivalent experience)
- 5 years of experience in DevOps, Security Engineering, or DevSecOps roles
- Experience supporting regulated systems in life sciences or healthcare environments
- Hands-on experience with cloud platforms (AWS, Azure, or GCP) in validated environments
- Strong knowledge of GxP, CSV, and regulated SDLC practices
- Proficiency in scripting or programming (Python, Bash, PowerShell)
- Familiarity with IAM, encryption, audit logging, and data integrity controls
Preferred Qualifications
- Experience supporting clinical trial platforms (EDC, CTMS, eTMF, CDMS)
- Knowledge of FDA 21 CFR Part 11 and Annex 11 requirements
- Security or compliance certifications (CISSP, CISM, CCSK, or equivalent)