Clinical Data Systems Architect (EDC/AI)

McKesson’s Corporate; Town of Texas (WI); Hybrid; USD 91,000 - 151,000; Full time

Benefits offered by this job

Hybrid work arrangement

Job summary

McKesson is seeking a detail-oriented Clinical Data Systems Specialist to support eCRF development, EDC workflows, and AI-enabled clinical data solutions. This role partners with study teams, vendors, and operational stakeholders to improve data quality, workflow efficiency, compliance, and responsible use of automation and AI.

This position offers a hybrid work arrangement; in the DFW area some on-site days may be required.

Qualifications

• Degree or equivalent and typically requires 4+ years of relevant experience.
• 4+ years of experience in clinical data management, database development, eCRF systems, or EDC platform support.
• Knowledge of clinical trial processes, data management principles, ICH GCP, 21 CFR Part 11, CDISC CDASH, or SDTM standards.
• Programming or scripting experience with SQL, Python, R, Java, PL/SQL, T-SQL, or similar languages.
• Experience with AI, machine learning, automation, advanced analytics, or data quality tools in clinical research or healthcare data environments.
• Strong communication skills with the ability to collaborate across clinical, operational, technical, and vendor teams.

Responsibilities

• Coordinate eCRF development, EDC workflows, and system requirements for clinical research studies.
• Design, analyze, and optimize EDC tools, including forms, dictionaries, logic, reports, derivations, and custom functions.
• Develop OpenClinica workflows, SOPs, user guides, and standardized templates to support chart review and data abstraction.
• Serve as a subject matter expert in clinical data collection, unstructured data variables, and data quality expectations.
• Support AI-enabled tools and automation for data review, anomaly detection, query prioritization, trend identification, and workflow optimization.
• Ensure AI-supported outputs are documented, validated, reviewed appropriately, and used with human oversight.
• Partner with study teams, users, vendors, and cross-functional stakeholders to align workflows with project scope, timelines, quality standards, performance expectations, and risk considerations.

Skills

Clinical data management

EDC platforms

Clinical trial standards (ICH GCP/CDIC

SQL/Python/R/Java/PL-SQL

AI/ML and automation in clinical

Communication and collaboration

Education

Bachelor's degree in science, computer science, clinical research, or related field

Tools

OpenClinica

Medidata Rave

Oracle Clinical

Veeva Vault EDC

Job description

McKesson is seeking a detail-oriented Clinical Data Systems Specialist to support eCRF development, EDC workflows, and AI-enabled clinical data solutions. This role partners with study teams, vendors, and operational stakeholders to improve data quality, workflow efficiency, compliance, and responsible use of automation and AI.

This position offers a hybrid work arrangement; in the DFW area some on-site days may be required.