Clinical Data Systems Specialist: eCRF & AI

McKesson

United States

Hybrid

USD 91,000 - 151,000

Full time

2 days ago

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Benefits offered by this job

Hybrid work arrangement

Job summary

McKesson seeks a detail-oriented Clinical Data Systems Specialist to support eCRF development, EDC workflows, and AI-enabled clinical data solutions. You will partner with study teams, vendors, and stakeholders to improve data quality and workflow efficiency while ensuring compliance and responsible use of automation.

Minimum 4+ years in clinical data management and experience with OpenClinica or similar platforms are required.

Qualifications

4+ years in clinical data management or EDC support.
Experience with leading EDC platforms.
Familiarity with ICH-GCP, 21 CFR Part 11, and CDISC standards.
Programming or scripting in SQL, Python, or R.

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 templates to support chart review and data abstraction.
Serve as SME 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 outputs are documented, validated, 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.]