Remote Clinical Data Specialist: eCRF & AI-Driven QA

McKesson’s Corporate; Irving (TX); Hybrid; USD 91,000 - 151,000; Full time

Job summary

McKesson is seeking a Clinical Database Specialist to support eCRF design, EDC workflows, and AI-enabled clinical data solutions. You will collaborate with study teams, vendors, and stakeholders to improve data quality and workflow efficiency while ensuring compliance with HIPAA and regulatory standards.

The role requires 4+ years in clinical data management and experience with OpenClinica, Medidata Rave, or similar platforms. Hybrid work is available, with on-site days in the DFW area as needed.

Qualifications

• 4+ years of experience in clinical data management, database development, or EDC support.
• Bachelor’s degree in science, computer science, clinical research, or related field.
• Experience with OpenClinica, Medidata Rave, Oracle Clinical, Veeva Vault EDC or similar platforms.
• Knowledge of ICH-GCP, 21 CFR Part 11, CDISC/CDASH/SDTM standards.
• Programming or scripting with SQL, Python, R, Java, PL/SQL, T-SQL or equivalent.
• Experience with AI, machine learning, automation, or data quality tools in clinical research.

Responsibilities

• Coordinate eCRF development and EDC workflows for studies.
• Design and optimize EDC tools, forms, derivations, reports and dictionaries.
• Develop OpenClinica workflows, SOPs, user guides, and templates for data abstraction.
• Act as SME for clinical data collection, unstructured data, and data quality expectations.
• Support AI-enabled data review and automation with human oversight.
• Collaborate with study teams, vendors, and cross-functional stakeholders to align workflows.

Skills

SQL

Python

R

Java

Education

Bachelor's degree

Tools

OpenClinica

Medidata Rave

Oracle Clinical

Veeva Vault EDC

Job description

McKesson is seeking a Clinical Database Specialist to support eCRF design, EDC workflows, and AI-enabled clinical data solutions. You will collaborate with study teams, vendors, and stakeholders to improve data quality and workflow efficiency while ensuring compliance with HIPAA and regulatory standards.

The role requires 4+ years in clinical data management and experience with OpenClinica, Medidata Rave, or similar platforms. Hybrid work is available, with on-site days in the DFW area as needed.