Clinical Database Specialist (eCRF Design)

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

## Clinical Database Specialist (eCRF Design)Apply: Fully Remote: USA, TX, Remote: Full time: Posted Yesterday: JR0154320McKesson 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.* 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.# **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. For more information regarding benefits at McKesson, please click here.**Our Base Pay Range for this position**$90,600 - $151,000McKesson has become aware of online recruiting-related scams in which individuals who are not affiliated with or authorized by McKesson are using McKesson’s (or affiliated entities, like CoverMyMeds or RxCrossroads) name in fraudulent emails, job postings or social media messages. In light of these scams, please bear the following in mind: McKesson Talent Advisors will never solicit money or credit card information in connection with a McKesson job application.McKesson Talent Advisors do not communicate with candidates via online chatrooms or using email accounts such as Gmail or Hotmail. Note that McKesson does rely on a virtual assistant (Gia) for certain recruiting-related communications with candidates.McKesson job postings are posted on our career site: careers.mckesson.com.**McKesson is an Equal Opportunity Employer**McKesson provides equal employment opportunities to applicants and employees, without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, age, genetic information, or any other legally protected category. For additional information on McKesson’s full Equal Employment Opportunity policies, visit our Equal Employment Opportunity page.McKesson is committed to being an Equal Employment Opportunity Employer and offers opportunities to all job seekers including job seekers with disabilities. If you need a reasonable accommodation to assist with your job search or application for employment, please contact us by sending an email to (United States) Disability\\[e-mail] or (Canada) [e-mail]. Resumes or CVs submitted to this email box will not be accepted.