Senior Manager, Clinical Data Systems & Strategy

Regulatory Jobs; Irvine (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

AbbVie Data Science is the best-in-class team within its cross-industry peer group and is responsible for turning clinical trials data into business value through people, processes, and technology.

This role will manage multiple therapeutic area initiatives, oversee data loading, SDTM/CDASH standards, and coordinate internal and external resources to ensure timely, high-quality regulatory deliverables.

Qualifications

• Bachelor’s degree in MIS, CS, life sciences or equivalent.
• 8+ years in clinical database design, data loading, or similar.
• Demonstrated SAS/SQL programming and database concepts.
• Knowledge of CDASH and SDTM standards; strong communication.
• Ability to influence without authority and coach in matrix orgs.

Responsibilities

• Manage multiple therapeutic areas and programs.
• Oversee technology evaluations for performance improvements.
• Provide strategic direction and resource management for staff.
• Ensure SDTM deliverables meet quality and regulatory standards.
• Mentor staff and drive continuous process improvements.

Skills

SAS programming

SQL programming

Data modeling

Analytical skills

Education

Bachelor's degree

Master's preferred

Tools

CDASH standards

SDTM standards

Job description

AbbVie Data Science is the best-in-class team within its cross-industry peer group and is responsible for turning clinical trials data into business value through people, processes, and technology.

This role will manage multiple therapeutic area initiatives, oversee data loading, SDTM/CDASH standards, and coordinate internal and external resources to ensure timely, high-quality regulatory deliverables.