Hybrid Clinical Systems Design Analyst II

SmartRecruiters, Inc.; North Chicago (IL); Hybrid; USD 85,000 - 162,000; Full time

Job summary

AbbVie's System Design Analyst II-Clinical Systems is a hybrid, full-time role in North Chicago, IL, focused on delivering robust clinical data systems. You will contribute to data standards, drive design quality, and guide a cross-functional team through EDC configurations and system integrations.

The role requires 5+ years in EDC, Medidata RAVE experience, and CDASH/SDTM expertise, with a strong emphasis on mentorship and regulatory compliance.

Qualifications

• 5+ years of hands-on technical Study build in EDC.
• Experience with technical study build in Medidata RAVE is required.
• Veeva EDC technical study build experience is a plus.
• In-depth knowledge of CDASH (Required) and SDTM.

Responsibilities

• Actively participates in the development of common data standards and ensures systems designs comply with the standards, as well as with associated protocol requirements.
• Establishes and maintains methodology used by the team to design and develop clinical trial systems, benchmarking against industry standards.
• Ensures that TA- and program-level consistency is achieved by the design team.
• Accountable for the on-time design and delivery of new clinical systems, integrations between systems, as well as any required changes to clinical systems (e.g., EDC, IRT, ePRO).
• Interacts with and influences CDO and cross-functional team members to achieve program and study objectives.
• Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie SOPs, and functional quality standards.
• Responsible for coaching and mentoring members of the team, as well as contributes to their skill development.
• Leads CDO and cross-functional innovation and process improvement initiatives.

Skills

EDC

Medidata RAVE

Veeva EDC

CDASH

SDTM

Education

Bachelor’s degree in business, MIS, CS, or life sciences

Masters preferred

Job description

AbbVie's System Design Analyst II-Clinical Systems is a hybrid, full-time role in North Chicago, IL, focused on delivering robust clinical data systems. You will contribute to data standards, drive design quality, and guide a cross-functional team through EDC configurations and system integrations.

The role requires 5+ years in EDC, Medidata RAVE experience, and CDASH/SDTM expertise, with a strong emphasis on mentorship and regulatory compliance.