Senior Clinical Data Engineer (LATAM)

Overview

We’re expanding our data engineering capabilities across Mexico, Brazil, Argentina, Colombia, Chile, and Peru, and we’re hiring a Senior Clinical Data Engineer to help build the foundation of this new regional function.

Responsibilities

The Senior Clinical Data Engineer leads the strategic development and optimization of clinical data systems to support regulatory compliance, advanced analytics, and operational excellence across global trials. This role drives enterprise‑level data standardization initiatives, architects scalable validation frameworks, and builds high‑performance databases and pipelines across global trials. It also oversees regulatory alignment with GCP and FDA 21 CFR Part 11, establishes robust documentation and audit trail protocols, delivers actionable insights via dashboards, and acts as a strategic liaison across Biostatistics, Clinical Operations, and Regulatory Affairs.

• Data Standardization & Mapping: Spearhead the development of enterprise‑level data mapping strategies that transform raw clinical data into standardized formats. Lead adoption and governance of data standards to ensure regulatory alignment and consistency.
• Data Quality Assurance: Design and implement robust, scalable validation frameworks that proactively detect and resolve systemic data issues. Serve as a strategic partner to Clinical Data Managers and cross‑functional teams, driving continuous improvement in data integrity across global trials.
• Programming & Scripting: Architect and maintain advanced modular codebases using Python, R, SQL, and SAS. Establish coding standards, mentor junior engineers, and support automation, reproducibility, and performance optimization.
• Regulatory Compliance & Documentation: Lead compliance initiatives to ensure all data systems and workflows meet GCP, FDA 21 CFR Part 11, and evolving global regulatory requirements. Define documentation protocols and oversee audit trail governance.
• Reporting & Visualization: Develop and operationalize dynamic dashboards and analytics tools that provide real‑time insights into data quality, trial progress, and operational KPIs.
• Collaboration & Cross‑Functional Support: Act as a strategic liaison between Clinical Data Engineering and Biostatistics, Clinical Operations, and Regulatory Affairs. Translate clinical and scientific requirements into scalable technical solutions.
• Database Design & Optimization: Lead the design and optimization of secure, high‑performance relational databases and data lakes. Ensure infrastructure scalability, query efficiency, and data governance.

Qualifications

Minimum Required

• Bachelor’s Degree in a relevant field (life sciences, statistics, data management, clinical operations) or an equivalent combination of education, training, and experience.
• Minimum 6 years of experience in clinical monitoring, clinical trial management, or equivalent.
• Advanced programming and automation skills; database design; dashboard development; CDISC governance.
• Professional working proficiency in English.

Other Required

• Highly effective oral and written communication skills with the ability to communicate effectively with project team members.
• Excellent organizational and time‑management skills.
• Ability to work in a team or independently as required.
• Demonstrated ability to extract pertinent information from protocols, electronic study data systems, and clinical systems.
• Proficiency in statistical analysis and data monitoring tools.
• Detail‑oriented with strong analytical and problem‑solving skills.
• Demonstrated experience with integrated risk planning & management.
• Ability to mentor junior team members.

Preferred

• CRO experience as a Clinical Data Engineer or Programmer.

Skills

• Strong analytical and problem‑solving skills with attention to data quality and integrity.
• Ability to work with large, complex datasets from multiple sources.
• Effective communication skills to collaborate with cross‑functional teams.
• Knowledge of data governance, privacy, and security best practices in clinical research.

Competencies

• Collaboration: Works effectively with clinical, statistical, and technical teams to align data strategies with study goals.
• Accountability: Takes ownership of data engineering deliverables and ensures timely, high‑quality outputs.
• Adaptability: Thrives in a fast‑paced, evolving environment with shifting priorities and timelines.
• Compliance‑Oriented: Maintains a strong focus on regulatory compliance and data traceability.

Equal Opportunity Employer Statement

Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.