GxP Domain Specialist: Data, Analytics & Compliance

Arcondis Group; México; Presencial; MXN 420.000 - 720.000; Jornada completa

Descripción de la vacante

Arcondis Group is seeking an experienced Domain Specialist to support GxP-regulated applications within Clinical Data Science and Clinical Operations. You will handle L2 application support, system lifecycle management, and ensure data integrity and compliance.

You will collaborate with IT, QA, validation, data teams and external vendors, coordinating upgrades, investigations, CAPAs, and inspection readiness, while aligning with data governance and regulatory requirements.

Formación

• Experience in Clinical Development, Data Science, or Clinical Operations.
• Strong understanding of GxP, CSV and regulatory compliance.
• Experience with multi-vendor environments.

Responsabilidades

• Provide extended L2 application support for SAS, Spotfire, and LabMatrix-related platforms.
• Support analytics, reporting, and BI through SAS, Spotfire, Databricks, and related data platforms.
• Coordinate investigations, CAPAs, audits, and RCA.
• Assist in validation, upgrades, and system retirement in line with GxP requirements.
• Create SOPs and training materials for users.

Conocimientos

Clinical data analysis

Data governance & integrity

Stakeholder management

English proficiency

Educación

Bachelor's degree

Master's degree

Herramientas

SAS

Spotfire

Metworx

Pinnacle21

nQuery

LabMatrix/B-SMART

Databricks

ServiceNow

Descripción del empleo

Arcondis Group is seeking an experienced Domain Specialist to support GxP-regulated applications within Clinical Data Science and Clinical Operations. You will handle L2 application support, system lifecycle management, and ensure data integrity and compliance.

You will collaborate with IT, QA, validation, data teams and external vendors, coordinating upgrades, investigations, CAPAs, and inspection readiness, while aligning with data governance and regulatory requirements.