Clinical Data Strategy & Operations Lead I

AbbVie; Chicago (IL); On-site; USD 130,000 - 180,000; Full time

Benefits offered by this job

Medical/dental/vision insurance

401(k)

Short-term incentive programs

Job summary

AbbVie in Chicago seeks an experienced leader for Clinical Data Strategy and Operations (CDSO) to ensure delivery against program- and study-level accountabilities. You will lead the CDSO Study Team and serve as the operational lead for assigned studies, coordinating global teams to meet objectives.

You will apply analytics and project-management tools, ensure compliance with GCPs, ICH, SOPs, and evolving regulations while mentoring Data Science Associates and driving CDSO improvements across

Qualifications

• Bachelor’s degree in business, MIS, CS, life sciences or equivalent. Master’s preferred.
• Must have 3+ yrs pharma / clinical research / data management / health care experience or 5+ yrs project management experience.
• Strong understanding of clinical trial process and clinical technology; experience managing a clinical trial is preferred.
• Demonstrated effective leadership, communication and analytical skills.

Responsibilities

• Aligns CDSO study teams with program- and study-level strategies and leads the CDSO Study Team.
• Acts as single point of contact and accountable operational lead from CDSO for assigned studies.
• Coordinates CDSO study teams with global functional and cross-functional teams.
• Uses operational analytics and project management tools to optimize execution and track study progress.
• Ensures adherence to GCPs, ICH guidelines, AbbVie SOPs and local regulations.
• Participates in CDSO and cross-functional innovation and process improvement initiatives.
• Mentors Data Science Associates and contributes to lessons learned across functions.

Skills

Clinical trial process

Clinical technology

Leadership

Influence without authority

Communication skills

Analytical skills

Education

Bachelor's degree in business / MIS / CS / life sciences

Master’s preferred; PMP / Lean Six Sigma Green Belt desired

Job description

AbbVie in Chicago seeks an experienced leader for Clinical Data Strategy and Operations (CDSO) to ensure delivery against program- and study-level accountabilities. You will lead the CDSO Study Team and serve as the operational lead for assigned studies, coordinating global teams to meet objectives.

You will apply analytics and project-management tools, ensure compliance with GCPs, ICH, SOPs, and evolving regulations while mentoring Data Science Associates and driving CDSO improvements across