Senior Clinical Data Engineer (LATAM)

OpenKrill; United States; Remote; USD 140,000 - 210,000; Full time

Job summary

Precision Medicine Group is expanding its data engineering capabilities and is seeking a Senior Clinical Data Engineer to design and optimize clinical data systems for global trials. The role emphasizes data standardization, validation, and scalable analytics pipelines using SAS, Python, and SQL.

You will mentor engineers, ensure FDA 21 CFR Part 11 compliance, and collaborate with Biostatistics, Clinical Operations, and Regulatory Affairs to deliver actionable insights and robust data

Qualifications

• Bachelor's degree in a life sciences, statistics, data management, or related field.
• 6+ years of experience in clinical data management, data engineering, or equivalent.
• Advanced programming, automation, and database design skills; dashboard development; CDISC governance.
• Professional working proficiency in English.

Responsibilities

• Lead development and optimization of clinical data systems to support regulatory compliance and analytics.
• Drive enterprise-wide data standardization and scalable validation frameworks.
• Architect high-performance databases and ETL pipelines across global trials.
• Mentor junior engineers and ensure auditability and regulatory alignment.

Skills

SAS Programming

Python

SQL

English proficiency

Education

Bachelor's degree in life sciences / data management / related field

Tools

SAS

Python

SQL

Job description

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. In this role, you’ll lead the development and optimization of clinical data systems, drive data standardization, build validation frameworks, and design high‑performance databases and pipelines across global trials.

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, and architects scalable validation frameworks to proactively address systemic data issues. With deep expertise in SAS Programming in a Life Sciences setting, you'll be responsible for building and maintaining modular codebases, sets coding standards, and mentoring junior engineers. The role also oversees regulatory alignment with GCP and FDA 21 CFR Part 11, establishing robust documentation and audit trail protocols.

Through dynamic dashboards and analytics tools, you'll deliver actionable insights into trial performance and data quality. As a strategic liaison across Biostatistics, Clinical Operations, and Regulatory Affairs, you'll help translate clinical requirements into scalable technical solutions and leads the design of secure, high-performance databases and ETL pipelines integrating data from diverse clinical systems.

Essential functions of the job include but are not limited to:

Data Standardization & Mapping: Spearhead the development of enterprise-level data mapping strategies that transform raw clinical data into standardized formats for high‑impact analytics. Lead the adoption and governance of data standards across programs 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 SAS to support complex data engineering workflows. Python, R, and SQL experience is highly preferred as we continue to leverage Ai tools across the industry. Establishing coding standards and mentoring junior engineers in automation, reproducibility, and performance optimization. Example use cases includes edit checks, reconciliations, exception listings, programmed protocol deviations, resource projections based on site data entry volume

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 to support inspection readiness and transparency.

Reporting & Visualization: Develop and operationalize dynamic dashboards and analytics tools that provide real‑time insights into data quality, trial progress, and operational KPIs. Translate complex datasets into actionable intelligence for clinical and regulatory stakeholders.

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 that support study execution and data delivery.

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 for large‑scale clinical datasets.

Qualifications

Minimum Required

• Bachelor’s Degree in a relevant field (life sciences, statistics, data management, clinical operations) or relevant/equivalent combination of education, training, and experience
• Minimum 6 years 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 learn how 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
• Automation and Ai Agent Deployment in Regulated Environments

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.

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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.

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