Sr. Principal Clinical Data and Solutions Architect
About The Position
The Clinical Business Intelligence team supports clinical trial execution, operational oversight, and portfolio decision-making through scalable data and analytics capabilities. It partners with Clinical Operations, Safety, Monitoring, Data Management, Biostatistics, IT, and enterprise architecture teams to provide governed data platforms, reporting solutions, and analytics products. The Senior Principal Clinical Data and Solutions Architect provides strategic leadership for clinical data, analytics, and reporting capabilities across the clinical research ecosystem. The role partners with business and technology stakeholders to define data products, modernize platforms, establish governance standards, and deliver scalable solutions that turn clinical data into actionable insights. The position is remote, with 10% travel required.
Requirements
- 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.
Nice To Haves
- Bachelor's degree in Biostatistics, Statistics, Data Science, Computer Science, or a quantitative discipline, and significant experience in clinical research data and analytics.
- Experience modernizing clinical data platforms, reporting environments, or enterprise analytics solutions.
- Experience with SQL, SQL Server, Power BI, or similar business intelligence and analytics platforms.
- Knowledge of ICH, GCP, FDA, and 21 CFR Part 11 requirements.
- Experience leading large-scale platform transformation, technology enablement, or data governance initiatives.
- Experience within medical device, pharmaceutical, CRO, or other regulated clinical research environments.
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 CDISC standards, including SDTM, ADaM, and 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 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.
Benefits
- Competitive salary and flexible benefits package.
- Short-term incentive through the Medtronic Incentive Plan (MIP).
- For regular employees working 20 or more hours per week: health, dental, and vision insurance; Health Savings Account; Healthcare Flexible Spending Account; life insurance; long-term disability leave; dependent daycare spending account; tuition assistance or reimbursement; and the Simple Steps global well-being program.
- For all regular employees: incentive plans; 401(k) plan with employer contribution and match; short-term disability; paid time off; paid holidays; Employee Stock Purchase Plan; Employee Assistance Program; Non-qualified Retirement Plan Supplement (subject to IRS earning minimums); and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).
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What This Job Offers
Job Type
Full-time
Career Level
Principal
