GxP Compliance Specialist – Clinical Trial Data

Ascendion; Seattle (WA); On-site; USD 150,000 - 155,000; Full time

Benefits offered by this job

medical insurance

dental insurance

vision insurance

401(k) retirement plan

long-term disability insurance

short-term disability insurance

paid time off

Job summary

Ascendion is seeking an experienced GxP Compliance Specialist to support an enterprise program that develops AI agents for clinical trial data workflows and FDA submission-ready packages. The role requires hands-on GxP compliance in a clinical trial environment, with ADaM datasets and TLF package submissions, plus collaboration with clinical and engineering teams to ensure regulatory alignment.

Based in or near Seattle, WA, you will work onsite two days per week; the position offers a

Qualifications

• Hands-on experience with GxP compliance in a clinical trial environment.
• Direct experience submitting ADaM datasets and TLF packages.
• Knowledge of FDA submission standards and clinical data packages.
• Ability to document compliance and communicate findings clearly.

Responsibilities

• Ensure clinical trial data workflows and outputs comply with GxP standards.
• Review data mappings and identify compliance gaps or deviations from FDA requirements.
• Collaborate with clinical and engineering teams to translate regulatory requirements into actionable guidance for AI development.
• Support audit readiness with documentation, traceability, and validation practices throughout the data pipeline.

Skills

GxP compliance

ADaM datasets

TLF packages

FDA submissions

Regulatory review

Clinical data lifecycle

Data mapping

Job description

Ascendion is seeking an experienced GxP Compliance Specialist to support an enterprise program that develops AI agents for clinical trial data workflows and FDA submission-ready packages. The role requires hands-on GxP compliance in a clinical trial environment, with ADaM datasets and TLF package submissions, plus collaboration with clinical and engineering teams to ensure regulatory alignment.

Based in or near Seattle, WA, you will work onsite two days per week; the position offers a