Clinical Data Strategy Lead - Study Start-Up

AbbVie Inc.; North Chicago (IL); Hybrid; USD 150,000 - 190,000; Full time

Benefits offered by this job

Hybrid work arrangement

Medical/dental/vision insurance

401(k)

Job summary

AbbVie is seeking a CDSO Data Strategy Lead to own data-related start-up deliverables from protocol development through system go-live. You will partner with study teams to embed data strategies, standards, and technologies into clinical plans, guiding decisions with analytics and risk oversight.

The role requires 6+ years in pharma/clinical data or 8+ years PM, with strong leadership, communication, and coaching skills in a hybrid work environment.

Qualifications

• Bachelor’s degree in business, MIS, CS, life sciences or equivalent; Master’s preferred.
• 6+ years pharma/clinical research/data management or 8+ years project management experience.
• In‑depth understanding of clinical trial processes and clinical technology.
• Demonstrated performance as a functional leader and ability to influence without authority.
• Strong communication and analytical abilities; coaching/mentoring capability.

Responsibilities

• Serves as the CDSO study start-up SME and single point of contact for assigned studies, owning all data-related start-up deliverables.
• Leads data management study start-up end-to-end; coordinates with CDSO and study teams to enable on-time start and issue resolution.
• Ensures consistency in data strategy, standards, CRFs, and surveillance across studies and therapeutic areas.
• Translates data, technology, and standards concepts into clear, decision-ready guidance for study teams.
• Drives critical-to-quality factors and data criticality assessments into downstream data systems.
• Ensures adherence to GCPs, ICH guidelines, AbbVie SOPs, and evolving guidance; demonstrates effective communication.
• Influences without direct authority to drive aligned outcomes for AbbVie.
• Leads CDSO innovation and cross-functional initiatives; coaches and mentors team members.

Skills

Project leadership

Influence without authority

Coaching/mentoring

Communication skills

Analytical skills

Project management

Education

Bachelor’s degree in business, MIS, CS, life sciences; Master’s preferred

PMP Certification or Lean Six Sigma Green Belt desired

Job description

AbbVie is seeking a CDSO Data Strategy Lead to own data-related start-up deliverables from protocol development through system go-live. You will partner with study teams to embed data strategies, standards, and technologies into clinical plans, guiding decisions with analytics and risk oversight.

The role requires 6+ years in pharma/clinical data or 8+ years PM, with strong leadership, communication, and coaching skills in a hybrid work environment.