GxP Compliance Specialist in Clinical Trial Data

About AscendionAbout AscendionAscendion 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™, EngineeringAI, Engineering to Elevate Life™, Enterprise PlatformsAI, Data & InsightsAI, ExperienceAI, GCCAI, OperationsAI, Platform EngineeringAI, ProductAI, and Quality EngineeringAIare trademarks or service marks of Ascendion®. AAVA™ is pending registration. Unauthorized use is strictly prohibited.Ascendion | Engineering to elevate lifeWe 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 brandsSolve complex problems - and learn new skillsExperience the power of transforming digital engineering for Fortune 500 clientsMaster your craft with leading training programs and hands-on experienceExperience 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 AscendionAscendion 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 ProgramsLocation:Seattle, WA - Hybrid (2 days onsite per week)Position OverviewAscendion is seeking an experiencedGxP Compliance Specialistto 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 ResponsibilitiesEnsure clinical trial data workflows and outputs comply with GxP standards and regulatory expectations.Provide hands-on expertise in ADaM dataset structures and TLF package development, reviewing and validating outputs against actual clinical trial submission standards.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.Identify compliance risks and recommend corrective actions.Contribute clinical data and regulatory expertise to improve data quality, standards adherence, and submission readiness at scale.Required QualificationsProven, hands-on experience withGxP compliance in a clinical trial environment.Direct experience submittingADaM 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 QualificationsExperience evaluating or working alongside AI/ML-driven data tools in a clinical or regulatory environment.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 :The Company offers the following benefits for this position, subject to applicable eligibility requirements: [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!