GxP Compliance Specialist in 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

GxP Compliance Specialist in Clinical Trial Data

Ascendion is an AI-native software engineering disruptor helping businesses innovate faster, smarter, and with greater impact. We partner with enterprise clients across North America, the UK, Europe, and APAC to solve complex challenges in data, experience design, software product engineering, and workforce transformation. Powered by expert engineers, thousands of AI agents, and our Engineering to the Power of AI (EngineeringAI) method, we deliver measurable outcomes that build trust, unlock value, and accelerate growth. Learn more at https://ascendion.com/.

Engineering to the Power of AI™, AAVA™, Engineering AI , Engineering to Elevate Life™ , Enterprise Platforms AI , Data & Insights AI , Experience AI , GCC AI , Operations AI , Platform Engineering AI , Product AI , and Quality Engineering AI are trademarks or service marks of Ascendion ® . AAVA™ is pending registration. Unauthorized use is strictly prohibited.

We have a culture built on opportunity, inclusion, and a spirit of partnership. Come, change the world with us:

• Build the coolest tech for the world’s leading brands
• Experience the power of transforming digital engineering for Fortune 500 clients
• Master your craft with leading training programs and hands-on experience

Experience a community of change makers!

Join a culture of high-performing innovators with endless ideas and a passion for tech. Our culture is the fabric of our company, and it is what makes us unique and diverse. The way we share ideas, learning, experiences, successes, and joy allows everyone to be their best at Ascendion.

About Ascendion

Ascendion is a full-service digital engineering solutions company. We make and manage software platforms and products that power growth and deliver captivating experiences to consumers and employees. Our engineering, cloud, data, experience design, and talent solution capabilities accelerate transformation and impact for enterprise clients. Headquartered in New Jersey, our workforce of 6,000+ Ascenders delivers solutions from around the globe. Ascendion is built differently to engineer the next.

Experience a community of change makers!

Join a culture of high-performing innovators with endless ideas and a passion for tech. Our culture is the fabric of our company, and it is what makes us unique and diverse. The way we share ideas, learning, experiences, successes, and joy allows everyone to be their best at Ascendion.

Hiring: GxP Compliance Specialist – Clinical Trial Data & Submission Programs

Position Overview

• Ascendion is seeking an experienced GxP Compliance Specialist to support an enterprise program developing AI agents for clinical trial data workflows, specifically solutions that map raw clinical trial data into FDA submission-ready packages.
• This role requires hands-on expertise in GxP compliance, clinical trial data standards, ADaM datasets, and TLF (Tables, Listings, and Figures) package development. The specialist will work closely with clinical and engineering teams to validate AI-generated outputs, identify compliance gaps, and ensure data mapping and submission packages align with regulatory requirements and FDA submission standards.
• This is a specialized individual-contributor role focused on regulatory compliance, data standards, and submission readiness rather than general program management.

Key Responsibilities

• Ensure clinical trial data workflows and outputs comply with GxP standards and regulatory expectations.
• Review raw-to-submission data mapping logic and identify compliance gaps or deviations from FDA requirements.
• Collaborate with technical and engineering teams to translate regulatory requirements into actionable guidance for AI agent development.
• Support audit readiness by ensuring appropriate documentation, traceability, and validation practices throughout the data pipeline.

Required Qualifications

• Proven, hands-on experience with GxP compliance in a clinical trial environment .
• Direct experience submitting ADaM datasets and TLF packages for actual clinical trial submissions .
• Strong understanding of the clinical trial data lifecycle, from raw/source data through FDA-submittable formats.
• Working knowledge of FDA submission standards and expectations for clinical and statistical data packages.
• Ability to critically review technical and data outputs, including AI-generated outputs, against regulatory requirements.
• Strong written communication skills, with the ability to provide precise compliance documentation and actionable feedback.
• Based in or near Seattle, WA, with the ability to work onsite two days per week.

Preferred Qualifications

• Familiarity with CDISC and SDTM standards in addition to ADaM.
• Experience supporting FDA audits or inspection-readiness activities.

Salary Range: The salary for this position is between $150,000 - $155,000 annually. Factors which may affect pay within this range may include geography/market, skills, education, experience and other qualifications of the successful candidate.

Benefits :

• medical insurance
• dental insurance
• vision insurance
• 401(k) retirement plan
• long-term disability insurance
• short-term disability insurance
• personal days accrued each calendar year. The Paid time off benefits meet the paid sick and safe time laws that pertains to the City/ State
• 12-15 days of paid vacation time
• 6-8 weeks of paid parental leave after a year of service
• 9 paid holidays and 2 floating holidays per calendar year
• Ascendion Learning Management System
• Tuition Reimbursement Program

Want to change the world? Let us know.

Tell us about your experiences, education, and ambitions. Bring your knowledge, unique viewpoint, and creativity to the table. Let's talk!

Preferred Skills

GXP

• Clinical Trial Submisson
• FDA
• TLF
• ADaM DataSets

Job details

Job ID 333242

Role GxP Compliance Specialist in Clinical Trial Data

Ascendion is a full-service digital engineering solutions company. We make and manage software platforms and products that power growth and deliver captivating experiences to consumers and employees.

Our engineering, cloud, data, experience design, and talent solution capabilities accelerate transformation and impact for enterprise clients. Headquartered in New Jersey, our workforce of 6,000+ Ascenders delivers solutions from around the globe. Ascendion is built differently to engineer the next.