Sr. Principal Clinical Data and Solutions Architect

• →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.

• 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.

• 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.

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.

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The following benefits and additional compensation are available to those regular employees who work 20+ 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/reimbursement, and Simple Steps (global well-being program).

The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus 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).

Regular employees are those who are not temporary, such as interns.  Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

Further details are available at the link below:

Medtronic benefits and compensation plans

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