ProPharma Group
Data Architect, Clinical Data Strategy & Products
ProPharma Group, Raleigh, North Carolina, United States, 27601
Data Architect
For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners' most high-profile drug and device programs. We are seeking a Data Architect to work with enterprise architects, data engineers, data product owners in the design and delivery of end-to-end data delivery. The candidate will oversee the implementation of a multi-tier data strategy that leverages reusable data products to deliver actionable insights with clinical data. This role will carry out and operationalize the architectural vision, guide development teams, and ensure all data solutions align with the defined strategy. The ideal candidate combines deep clinical data expertise, experience with Veeva Vault integration, and proficiency in managing clinical results data across complex ecosystems. Key Responsibilities
Architect solutions carrying out the Multi-Tier Data Strategy: Define and maintain a tiered architecture (e.g., Raw ? Standardized ? Curated ? Data Products) with clear governance, lineage, and SLAs. Establish principles for data product design (ownership, contracts, discoverability, versioning).
Guide Implementation & Development: Provide architectural oversight for ingestion, transformation, and serving layers. Ensure development teams adhere to architectural standards and best practices for scalability, security, and compliance.
Clinical Data Expertise: Design solutions for clinical operations, and clinical trial results. Integrate Veeva Vault Clinical and other CTMS/eTMF systems into the data ecosystem. Normalize data using healthcare standards (FHIR, HL7, CDA, DICOM) and terminologies (SNOMED, LOINC, RxNorm, ICD-10).
Data Products & Insights: Define and publish domain-oriented data products (e.g., Patient 360, Clinical Trial Outcomes, Quality Measures). Enable analytics and AI/ML use cases through well-structured, governed data layers.
Governance & Compliance: Implement architectural controls for HIPAA, HITRUST, SOC 2, and GxP compliance. Drive metadata management, lineage tracking, and cataloging for discoverability.
Required Qualifications
10+ years in data architecture or engineering roles, with at least 5 years in healthcare/clinical domains.
Proven experience designing multi-tier data strategies and data product frameworks.
Strong knowledge of clinical data standards (FHIR, HL7, CDA, DICOM) and vocabularies.
Hands-on experience with Veeva Vault Clinical integration and managing clinical trial results.
Expertise in AWS data services (S3, Glue, EMR, Redshift, Lake Formation) and AWS for Health offerings.
Deep understanding of security and compliance for PHI and clinical trial data.
Preferred Skills
Familiarity with CDISC standards (SDTM, ADaM) and regulatory submission workflows.
Experience with data mesh principles and domain-driven architecture.
Knowledge of interoperability standards (SMART on FHIR, OAuth2).
Strong communication and leadership skills to influence cross-functional teams.
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed. All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not. ***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***
For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners' most high-profile drug and device programs. We are seeking a Data Architect to work with enterprise architects, data engineers, data product owners in the design and delivery of end-to-end data delivery. The candidate will oversee the implementation of a multi-tier data strategy that leverages reusable data products to deliver actionable insights with clinical data. This role will carry out and operationalize the architectural vision, guide development teams, and ensure all data solutions align with the defined strategy. The ideal candidate combines deep clinical data expertise, experience with Veeva Vault integration, and proficiency in managing clinical results data across complex ecosystems. Key Responsibilities
Architect solutions carrying out the Multi-Tier Data Strategy: Define and maintain a tiered architecture (e.g., Raw ? Standardized ? Curated ? Data Products) with clear governance, lineage, and SLAs. Establish principles for data product design (ownership, contracts, discoverability, versioning).
Guide Implementation & Development: Provide architectural oversight for ingestion, transformation, and serving layers. Ensure development teams adhere to architectural standards and best practices for scalability, security, and compliance.
Clinical Data Expertise: Design solutions for clinical operations, and clinical trial results. Integrate Veeva Vault Clinical and other CTMS/eTMF systems into the data ecosystem. Normalize data using healthcare standards (FHIR, HL7, CDA, DICOM) and terminologies (SNOMED, LOINC, RxNorm, ICD-10).
Data Products & Insights: Define and publish domain-oriented data products (e.g., Patient 360, Clinical Trial Outcomes, Quality Measures). Enable analytics and AI/ML use cases through well-structured, governed data layers.
Governance & Compliance: Implement architectural controls for HIPAA, HITRUST, SOC 2, and GxP compliance. Drive metadata management, lineage tracking, and cataloging for discoverability.
Required Qualifications
10+ years in data architecture or engineering roles, with at least 5 years in healthcare/clinical domains.
Proven experience designing multi-tier data strategies and data product frameworks.
Strong knowledge of clinical data standards (FHIR, HL7, CDA, DICOM) and vocabularies.
Hands-on experience with Veeva Vault Clinical integration and managing clinical trial results.
Expertise in AWS data services (S3, Glue, EMR, Redshift, Lake Formation) and AWS for Health offerings.
Deep understanding of security and compliance for PHI and clinical trial data.
Preferred Skills
Familiarity with CDISC standards (SDTM, ADaM) and regulatory submission workflows.
Experience with data mesh principles and domain-driven architecture.
Knowledge of interoperability standards (SMART on FHIR, OAuth2).
Strong communication and leadership skills to influence cross-functional teams.
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed. All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not. ***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***