Clinical Informatics Process Reengineering Specialist

GAP SOLUTIONS INC; Bethesda (MD); On-site; USD 90,000 - 130,000; Full time

Job summary

GAP Solutions Inc. is seeking an experienced professional for a role focused on Computer Systems Validation/Assurance within NIH CIB Enterprise Clinical Informatics Systems in Bethesda, MD. The position emphasizes regulatory compliance and collaboration with cross-functional teams.

Responsibilities include updating systems for health authority requirements, managing access controls, and supporting inspections while ensuring the validated state of systems and adherence to SOPs.

Qualifications

• Bachelor’s Degree is required.
• Requires six years of relevant experience.
• FDA and ICH requirements (e.g., 21 CFR Part 11) experience preferred.
• Quality Management Systems experience preferred.

Responsibilities

• Perform Computer Systems Validation/Assurance activities and tasks.
• Update CIB systems to support health authority requirements.
• Develop processes and procedures to support regulatory compliance.
• Support validation/assurance of NIAID CIB Enterprise Clinical Informatics Systems.
• Respond to validation findings and implement corrective actions.
• Support health authority inspections.
• Maintain validated state of CIB systems and related servers/software.

Skills

Communication skills

Detail-oriented

Organizational skills

Prior FDA/ICH experience

Education

Bachelor's Degree

Job description

GAP Solutions Inc. is seeking an experienced professional for a role focused on Computer Systems Validation/Assurance within NIH CIB Enterprise Clinical Informatics Systems in Bethesda, MD. The position emphasizes regulatory compliance and collaboration with cross-functional teams.

Responsibilities include updating systems for health authority requirements, managing access controls, and supporting inspections while ensuring the validated state of systems and adherence to SOPs.