Clinical Systems Design Architect

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

Benefits offered by this job

PTO

Medical/Dental/Vision

401(k)

Job summary

AbbVie is seeking a Data Scientist to drive clinical data strategy within the Data Science team. The role focuses on delivering scalable clinical data systems and maintaining data standards across projects.

You will work with cross-functional partners to implement robust data flows and ensure compliance with regulatory requirements. The position requires 5+ years of hands-on EDC experience, knowledge of CDASH/SDTM, and the ability to mentor colleagues while driving process improvements in a

Qualifications

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

Responsibilities

• Develop common data standards and ensure designs comply with standards and protocol requirements.
• Establish and maintain methodology to design and develop clinical trial systems; optimize functionality, UX, and data flow.
• Ensure TA- and program-level consistency by the design team.
• Deliver on-time design and delivery of new clinical systems and integrations; track progress and propose solutions.
• Interact with CDO and cross-functional teams to meet objectives and synchronize dependencies.
• Ensure adherence to GCP, ICH guidelines, AbbVie SOPs, and evolving regulations.
• Coach and mentor team members; lead innovation and process improvement initiatives.

Skills

EDC experience

Data standards

CDASH/SDTM

Program coordination

Mentoring

Communication

Analytical skills

Influence without authority

Education

Bachelor's degree in business, MIS, CS, life sciences or equivalent; Masters preferred

Tools

Medidata RAVE

Veeva EDC

Job description

AbbVie is seeking a Data Scientist to drive clinical data strategy within the Data Science team. The role focuses on delivering scalable clinical data systems and maintaining data standards across projects.

You will work with cross-functional partners to implement robust data flows and ensure compliance with regulatory requirements. The position requires 5+ years of hands-on EDC experience, knowledge of CDASH/SDTM, and the ability to mentor colleagues while driving process improvements in a