Clinical Data Strategy Lead — Start-Up & Trials (Hybrid)

AbbVie; North Chicago (IL); Hybrid; USD 150,000 - 210,000; Full time

Benefits offered by this job

401(k)

Medical insurance

Dental insurance

Vision insurance

Paid time off

Job summary

AbbVie is seeking a CDSO Data Strategy Lead to own data-related study start-up from protocol to go-live. You will lead cross-functional collaboration to embed data strategies into clinical plans, manage risk, and drive technology delivery across trials.

The role requires strong project management, leadership in a matrix environment, and a commitment to process optimization while ensuring regulatory compliance and high-quality outcomes.

Qualifications

• Bachelor’s degree in business, MIS, computer science, life sciences or equivalent. Master’s preferred.
• Must have 6+ years pharma/clinical research/data management or 8+ years project management experience.
• In-depth understanding of clinical trial processes and clinical technology; lead role preferred.
• Demonstrated leadership and ability to influence without direct authority.
• Strong coaching/mentoring abilities in a matrix environment.
• Effective communication and analytical skills.

Responsibilities

• Acts as CDSO study start-up SME and single point of contact for assigned studies.
• Leads data management study start-up end-to-end to enable on-time study start.
• Ensures data strategy, CRFs, and surveillance standards are consistent across studies.
• Translates complex data/tech concepts into clear, decision-ready guidance.
• Ensures adherence to GCPs, ICH guidelines, AbbVie SOPs and regulatory standards.
• Drives data-criticality assessments and downstream data systems alignment.
• Champions CDSO innovation and process improvements across functions.
• Coaches and mentors team members.

Skills

Data strategy

Project management

Cross-functional collaboration

Regulatory knowledge

Coaching/mentoring

Communication skills

Analytical skills

Education

Bachelor’s degree or higher

Master’s degree preferred

Job description

AbbVie is seeking a CDSO Data Strategy Lead to own data-related study start-up from protocol to go-live. You will lead cross-functional collaboration to embed data strategies into clinical plans, manage risk, and drive technology delivery across trials.

The role requires strong project management, leadership in a matrix environment, and a commitment to process optimization while ensuring regulatory compliance and high-quality outcomes.