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 (Engineering AI) method, we deliver measurable outcomes that build trust, unlock value, and accelerate growth.

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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

• 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.

• 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…