Clinical Data Systems Lead — IRT/RTSM & Data Ops

Regulatory Toolkit; Chicago (IL); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k) and long-term incentives

Job summary

AbbVie Data Science is seeking a senior leader to drive clinical data initiatives and manage talent across multiple Therapeutic Areas. The role emphasizes IRT/RTSM SDLC mastery, governance, and a strong statistical programming foundation.

The candidate will guide technology evaluations, implement cost-reduction strategies, and ensure processes meet regulatory standards while mentoring staff and promoting a high-performing team culture.

Qualifications

• Must have IRT/RTSM SDLC understanding.
• IRT/RTSM Vendor Management/Governance experience required.
• Must have people management experience.
• Experience with clinical database design, data loading, and database modeling concepts.
• Knowledge of CDASH and SDTM standards.

Responsibilities

• Manage multiple Therapeutic Areas (TAs).
• Lead a team and provide former people leadership experience.
• Oversee technology evaluations and implementations for performance improvement and cost reduction.
• Create an environment that attracts, develops and retains strong talent.
• Drive continuous improvement of processes and technology usage.
• Act as subject matter expert and process owner.
• Supervise and allocate internal and external resources within Therapeutic Areas.
• Ensure performance assessments, training, feedback and retention efforts for staff.

Skills

IRT/RTSM experience

People management

SAS/SQL programming

Data modeling concepts

CDASH/SDTM knowledge

Education

Bachelor’s degree in MIS/CS/Life sciences

Master’s degree preferred

Tools

SAS

SQL

Job description

AbbVie Data Science is seeking a senior leader to drive clinical data initiatives and manage talent across multiple Therapeutic Areas. The role emphasizes IRT/RTSM SDLC mastery, governance, and a strong statistical programming foundation.

The candidate will guide technology evaluations, implement cost-reduction strategies, and ensure processes meet regulatory standards while mentoring staff and promoting a high-performing team culture.