Clinical Data Systems Designer II – EDC/SDTM Expert

Allergan; North Chicago (IL); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Comprehensive benefits package

Short-term incentive programs

401(k) plan

Job summary

AbbVie is seeking a data science professional to join its Clinical Data Strategy Organization to ensure timely design and delivery of clinical data systems. You will establish data standards, manage integrations, and coordinate with cross-functional teams to meet study objectives.

The role requires advanced EDC experience (Medidata RAVE), knowledge of CDASH/SDTM, and strong regulatory compliance awareness. A Master’s degree is preferred and mentorship of colleagues is expected.

Qualifications

• Bachelor’s degree in business, MIS, CS, life sciences or equivalent; Master’s preferred.
• 5+ years hands-on EDC study build experience; Medidata RAVE required; Veeva EDC a plus.
• Strong knowledge of clinical trial processes, CDASH and SDTM.
• Proven ability to influence others and coach in a matrixed environment.

Responsibilities

• Develop and maintain clinical data standards and system designs.
• Ensure designs meet protocol requirements and data flow needs.
• Deliver on-time design and integrations for clinical systems (EDC/IRT/ePRO).
• Coordinate with cross-functional teams to meet study objectives.
• Ensure regulatory compliance with GCP, ICH, SOPs and policies.
• Mentor team members and drive process improvements.

Skills

Medidata RAVE

Veeva EDC

CDASH

SDTM

Clinical trial processes

Data standards

Communication

Influence skills

Education

Bachelor’s degree in related field

Master’s degree preferred

Tools

Medidata RAVE

Veeva EDC

EDC systems

Job description

AbbVie is seeking a data science professional to join its Clinical Data Strategy Organization to ensure timely design and delivery of clinical data systems. You will establish data standards, manage integrations, and coordinate with cross-functional teams to meet study objectives.

The role requires advanced EDC experience (Medidata RAVE), knowledge of CDASH/SDTM, and strong regulatory compliance awareness. A Master’s degree is preferred and mentorship of colleagues is expected.