Clinical Database Specialist (eCRF Design)

McKesson; United States; Hybrid; USD 91,000 - 151,000; Full time

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.]

Skills

Clinical data management

Data quality assurance

Cross-functional collaboration

SQL/Python scripting

Regulatory compliance

Education

Bachelor's degree in life sciences or related field

Tools

OpenClinica

Medidata Rave

Oracle Clinical

Veeva Vault EDC

Job description

McKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of healthcare. We are known for delivering insights, products, and services that make quality care more accessible and affordable. Here, we focus on the health, happiness, and well‑being of you and those we serve - we care.

What you do at McKesson matters. We foster a culture where you can grow, make an impact, and are empowered to bring new ideas. Together, we thrive as we shape the future of health for patients, our communities, and our people. If you want to be part of tomorrow's health today, we want to hear from you.

We are 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.

Key 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.

Minimum Requirement

Degree or equivalent and typically requires 4+ years of relevant experience.

Education

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

Critical Skills

• 4+ years of experience in clinical data management, database development, eCRF systems, or EDC platform support.
• Experience with OpenClinica, Medidata Rave, Oracle Clinical, Veeva Vault EDC, or similar platforms.
• 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.

This position offers the possibility of a hybrid work arrangement based on recent updates to our in‑office/work‑from‑home model. If located in DFW area, the selected candidate may be expected to work on‑site at our Las Colinas office a minimum of two (2) days per week, with the remaining days worked remotely. Specific in‑office days may be designated according to team needs and business priorities.

We are proud to offer a competitive compensation package at McKesson as part of our Total Rewards. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. The pay range shown below is aligned with McKesson's pay philosophy, and pay will always be compliant with any applicable regulations. In addition to base pay, other compensation, such as an annual bonus or long‑term incentive opportunities may be offered.

$90,600 - $151,000