Clinical Data Specialist: eCRF Design & AI-Driven EDC

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

Job summary

McKesson is seeking a data-focused professional to coordinate eCRF development and EDC workflows for clinical research studies in a hybrid US-based role. You will design, analyze, and optimize EDC tools and templates to support data abstraction and chart reviews.

The ideal candidate has 4+ years in clinical data management, experience with OpenClinica/Medidata Rave/Oracle Clinical, and knowledge of ICH-GCP, 21 CFR Part 11, and CDISC standards.

Qualifications

• 4+ years of experience in clinical data management or related field.
• Experience with OpenClinica, Medidata Rave, Oracle Clinical or Veeva Vault EDC.
• Knowledge of clinical trial processes, ICH-GCP, 21 CFR Part 11, CDISC/CDASH, SDTM standards.

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.
• Bring experience in clinical research, clinical data operations, data abstraction, or electronic data capture systems.
• Apply working knowledge of eCRF design, EDC build processes, edit checks, reporting, OpenClinica or similar EDC platforms, and responsible AI principles.
• Manage multiple priorities with strong attention to detail and problem-solving skills.
• Maintain compliance with HIPAA and patient confidentiality requirements.

Skills

Clinical data management

Communication

Problem-solving

SQL

Python

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 data-focused professional to coordinate eCRF development and EDC workflows for clinical research studies in a hybrid US-based role. You will design, analyze, and optimize EDC tools and templates to support data abstraction and chart reviews.

The ideal candidate has 4+ years in clinical data management, experience with OpenClinica/Medidata Rave/Oracle Clinical, and knowledge of ICH-GCP, 21 CFR Part 11, and CDISC standards.