Sr. Principal Clinical Data and Solutions Architect
About the role
A Day in the Life
The Clinical Business Intelligence team supports clinical trial execution, operational oversight, and portfolio decision-making through scalable data and analytics capabilities. The team partners with Clinical Operations, Safety, Monitoring, Data Management, Biostatistics, IT, and enterprise architecture teams to deliver governed data platforms, reporting solutions, and analytics products that improve visibility into clinical performance and enable data-driven decision-making.
As a Senior Principal Clinical Data and Solutions Architect, you will provide strategic leadership for clinical data, analytics, and reporting capabilities across the clinical research ecosystem. You will partner with business and technology stakeholders to define data products, modernize platforms, establish governance standards, and deliver scalable solutions that transform clinical data into actionable insights.
At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. This position is remote to enhance our competitive edge and expand our cross-functional collaboration efforts. This role will require 10% travel to enhance collaboration and ensure successful completion of projects.
Primary Responsibilities
- Define and lead the evolution of clinical data, analytics, and reporting platforms supporting clinical trial execution and portfolio management.
- Develop scalable data products, semantic models, reporting frameworks, and self-service analytics capabilities.
- Apply Clinical Data Interchange Standards Consortium (CDISC) standards, including Study Data Tabulation Model (SDTM), Analysis Data Model (ADaM), and Unified Study Definitions Model (USDM), within data, analytics, and reporting solutions.
- Partner with Information Technology and enterprise architecture teams to design and support cloud-based clinical data platforms, including Amazon Web Services (AWS) environments.
- Lead modernization initiatives involving legacy system transformation, data migration, integration, and interoperability.
- Establish standards for data governance, quality, traceability, validation, metric consistency, and regulatory compliance.
- Oversee the development and adoption of clinical dashboards, analytics solutions, and operational reporting capabilities.
- Support platform strategy, vendor evaluations, solution oversight, validation activities, and investment planning.
Required Qualifications
- Bachelor's degree.
- Experience applying CDISC standards, including SDTM, ADaM, and USDM, within clinical data, analytics, or reporting environments.
- Experience with cloud-based data platforms in regulated environments, including AWS technologies.
- Experience supporting clinical trial execution, operational reporting, analytics, or clinical portfolio decision-making.
- Experience partnering with business stakeholders, Information Technology, and architecture teams to deliver data and analytics solutions.
Preferred Qualifications
- Bachelor's degree in Biostatistics, Statistics, Data Science, Computer Science, or quantitative discipline and significant experience in clinical research data and analytics.
- Experience modernizing clinical data platforms, reporting environments, or enterprise analytics solutions.
- Experience with Structured Query Language (SQL), SQL Server, Power BI, or similar business intelligence and analytics platforms.
- Knowledge of International Council for Harmonisation (ICH), Good Clinical Practice (GCP), Food and Drug Administration (FDA), and 21 CFR Part 11 requirements.
- Experience leading large-scale platform transformation, technology enablement, or data governance initiatives.
- Experience within medical device, pharmaceutical, contract research organization (CRO), or other regulated clinical research environments.
For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
Physical Job Requirements
U.S. Work Authorization & Sponsorship
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Medtronic offers a competitive Salary and flexible Benefits Package
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Skills
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