Lead Clinical Data Systems Architect for Life-Saving Trials

Emmes; Rockville (MD); On-site; USD 140,000 - 190,000; Full time

Job summary

Emmes Group in Rockville, MD is seeking a Principal Clinical Database Developer to lead EDC configurations, data validation, and CDISC SDTM/CDASH implementations within an Agile team. You will act as a technical SME, guide UAT, and mentor junior staff.

This role requires deep SQL proficiency, experience with eCRF design, and collaboration across therapeutic areas to ensure data integrity and regulatory compliance.

Qualifications

• Bachelor's Degree in analytic, technical, programming, or related discipline; required
• 7-9 years of progressive clinical database development experience (or master's with 6 years) and strong understanding of clinical research
• 4-6 years experience with eCRF design and specifications development
• 4-6 years experience writing, programming, or configuring data validation checks
• 4-6 years experience with QC, UAT, platform testing, and writing/executing test scripts
• 4-6 years knowledge of CDISC standards (CDASH, SDTM) and regulatory guidelines

Responsibilities

• Designs and configures electronic case report forms (eCRFs) including metadata, eCRF library, data checks, derivations, skip logic, rules, alerts, calculations.
• Configures complex protocols, visit schedules/folders and sites in the EDC system and advises on best approaches.
• Expertise in configuring features within EDC and related modules (ePRO, specimen tracking, randomization) as applicable.
• Evaluate complex requirements, determine feasibility, and implement novel solutions.
• Perform complex eCRF and data system QC, testing, and verification with high accuracy; mentor other teams.
• Writes and executes test scripts for complex configurations.
• Perform EDC releases (Test, Train, Production) and manage CRO library.
• Implement Data Validation Plans; write SQL or configure checks; review data changes; perform code review.
• Implement CDISC standards within EDC (CDASH/SDTM); support global standards development.
• Implement Data Migration Plans and data integration, upload, or transfer.
• Ensure compliance with industry standards and regulations (ICH/GCP).
• Use tracking systems to document configuration/testing and maintain SOPs; contribute to process improvements.
• May administer system modules or perform user/site administration across applications.
• Potentially serve as Product Owner/Scrum Master; mentor staff and contribute to agile processes.

Skills

eCRF design

SQL

CDISC SDTM

CDASH

UAT

Agile/Scrum

Mentorship

Education

Bachelor's Degree in analytic/technical discipline

Tools

EDC systems

SQL-based validation

Job description

Emmes Group in Rockville, MD is seeking a Principal Clinical Database Developer to lead EDC configurations, data validation, and CDISC SDTM/CDASH implementations within an Agile team. You will act as a technical SME, guide UAT, and mentor junior staff.

This role requires deep SQL proficiency, experience with eCRF design, and collaboration across therapeutic areas to ensure data integrity and regulatory compliance.