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Remote, LATAM (Mexico, Brazil, Argentina, Colombia, Chile, or Peru). Full-time.This role leads the strategic development and optimization of clinical data systems to support regulatory compliance, advanced analytics, and operational excellence across global trials. The Senior Clinical Data Engineer drives enterprise-level data standardization, architects scalable validation frameworks, builds modular codebases, and designs secure high-performance databases and ETL pipelines integrating data from diverse clinical systems. Acts as a strategic liaison across Biostatistics, Clinical Operations, and Regulatory Affairs.Essential FunctionsData Standardization & Mapping: Develop enterprise-level data mapping strategies to transform raw clinical data into standardized formats. Lead adoption and governance of data standards across programs for regulatory alignment and consistency.Data Quality Assurance: Design and implement scalable validation frameworks to proactively detect and resolve systemic data issues. Partner with Clinical Data Managers and cross-functional teams to drive continuous improvement in data integrity across global trials.Programming & Scripting: Architect and maintain advanced, modular codebases using Python, R, SQL, and SAS for complex data engineering workflows. Establish coding standards and mentor junior engineers in automation, reproducibility, and performance optimization. Use cases include edit checks, reconciliations, exception listings, programmed protocol deviations, and resource projections based on site data entry volume.Regulatory Compliance & Documentation: Lead compliance initiatives ensuring all data systems meet GCP, FDA 21 CFR Part 11, and global regulatory requirements. Define documentation protocols and oversee audit trail governance for inspection readiness.Reporting & Visualization: Develop dynamic dashboards and analytics tools providing real-time insights into data quality, trial progress, and operational metrics. Translate complex datasets into actionable intelligence for clinical and regulatory stakeholders.Collaboration & Cross-Functional Support: Translate clinical and scientific requirements into scalable technical solutions supporting study execution and data delivery.Database Design & Optimization: Lead design and optimization of secure, high-performance relational databases and data lakes, ensuring scalability, query efficiency, and data governance for large-scale clinical datasets.QualificationsBachelor's degree in life sciences, statistics, data management, clinical operations, or equivalent combination of education and experienceMinimum 6 years of experience in clinical monitoring, clinical trial management, or equivalentAdvanced programming and automation skills; database design; dashboard development; CDISC governanceProfessional working proficiency in EnglishHighly effective oral and written communication skillsExcellent organizational and time management skillsAbility to work independently or within a teamProficiency in statistical analysis and data monitoring toolsDetail-oriented with strong analytical and problem-solving skillsDemonstrated experience with integrated risk planning and managementAbility to mentor junior team membersPreferredCRO experience as a Clinical Data Engineer or ProgrammerSkills & CompetenciesStrong analytical and problem-solving skills with attention to data quality and integrityAbility to work with large, complex datasets from multiple sourcesKnowledge of data governance, privacy, and security best practices in clinical researchCollaboration: works effectively with clinical, statistical, and technical teamsAccountability: takes ownership of deliverables and ensures timely, high-quality outputsAdaptability: thrives in a fast-paced environment with shifting prioritiesCompliance-Oriented: strong focus on regulatory compliance and data traceability