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 Python, R, SQL, and SAS, the engineer builds and maintains modular codebases, sets coding standards, and mentors 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, the engineer delivers actionable insights into trial performance and data quality. As a strategic liaison across Biostatistics, Clinical Operations, and Regulatory Affairs, the engineer translates 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 Python, R, SQL, and SAS to support complex data engineering workflows. Establish coding standards and mentor 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

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.

#LI-AG2 #LI-REMOTE

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 Python, R, SQL, and SAS, the engineer builds and maintains modular codebases, sets coding standards, and mentors 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, the engineer delivers actionable insights into trial performance and data quality. As a strategic liaison across Biostatistics, Clinical Operations, and Regulatory Affairs, the engineer translates 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 Python, R, SQL, and SAS to support complex data engineering workflows. Establish coding standards and mentor 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

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.

#LI-AG2 #LI-REMOTE

re you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a Regulatory Affairs Associate Consultant for 12 months Contract with possibility of extension to join one of our clients.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.  

Regulatory Affairs Jr. Specialist Consultant / Especialista Jr. de Asuntos Regulatorios

Location / Ubicación: Ciudad de México, México

Position Summary / Resumen del puesto:

Support the preparation, review and follow-up of regulatory submissions for medical devices, ensuring compliance with applicable regulations before health authorities such as COFEPRIS, enabling timely approvals and maintenance of product registrations.

Apoyar en la preparación, revisión y seguimiento de trámites regulatorios para dispositivos médicos, asegurando el cumplimiento de la normativa aplicable ante la autoridad sanitaria COFEPRIS, facilitando la obtención y mantenimiento de los registros sanitarios.

Key responsabilities / Responsabilidades principales:

• Prepare and compile regulatory documentation for COFEPRIS submissions (registrations, renewals, changes).
• Follow up on submissions with regulatory authority (COFEPRIS).
• Support interpretation of local and international regulations.
• Support coordination of requests and activities with cross-functional teams.
• Maintain updated regulatory files and databases.

• Preparar y compilar documentación regulatoria para sometimientos ante COFEPRIS (registros, renovaciones, modificaciones).
• Dar seguimiento a los trámites ante autoridad regulatoria (COFEPRIS).
• Apoyar en la interpretación de normativas locales e internacionales.
• Apoyar la coordinación de solicitudes y actividades con áreas internas.
• Mantener actualizados archivos regulatorios y bases de datos.

Qualifications / Requisitos:

Bachelor’s degree in Chemistry, Pharmaceutical Chemistry, Pharmacy, Biomedical Engineering, Biotechnology, or related field.

Licenciatura en Química, QFB, QFI, QBP, Farmacia, Ingeniería Biomédica, Biotecnología o afín.

Experience / Experiencia:

Minimum 1 year of experience in regulatory affairs, quality or medical device industry.

Technical skills / Conocimientos técnicos:

• Mexican medical device regulations (COFEPRIS).
• Medical device classification.
• NOMs and standards aplicable.
• Intermediate-advanced English (technical reading required).
• Intermediate Excel skills (data tracking, pivot tables, basic formulas, reporting).

Core competencies / competencias clave:

• Attention to detail.
• Organizational and documentation skills.
• Effective communication.
• Team collaboration
• Learning Agility.