Clinical Data Strategy Lead - Programs & Ops

AbbVie Inc.; South San Francisco (CA); On-site; USD 140,000 - 180,000; Full time

Job summary

AbbVie is seeking a CDSO Operations Lead to align study teams with program and study strategies. You will coordinate global CDSO study teams, oversee operational lead activities, and connect cross-functional groups to meet objectives.

You will guide analytics-driven execution, ensure regulatory compliance, and mentor data science staff while contributing to process improvements and lessons learned across studies.

Qualifications

• Bachelor’s degree in business, MIS, computer science or life sciences; Master’s preferred; PMP/Lean Six Sigma Green Belt desired.
• 3+ years pharma/clinical research/data management/health care experience or 5+ years project management experience.
• Strong understanding of clinical trial processes and clinical technology; experienced in managing trials.

Responsibilities

• Leads the CDSO Study Team and aligns with program- and study-level strategies.
• Acts as single point of contact and operational lead from CDSO for assigned studies.
• Coordinates CDSO study teams and engages global functional and cross-functional teams.
• Uses operational analytics and project management tools to optimize execution and track progress.
• Ensures adherence to GXP, ICH, AbbVie SOPs and local regulations.
• Mentors Data Science Associates and may supervise contract resources.
• Participates in CDSO and cross-functional innovation and process improvements.
• Contributes to study execution lessons learned across functions.

Skills

Project management

Leadership

Communication

Analytical skills

Education

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

Master’s degree preferred

PMP or Lean Six Sigma Green Belt desirable

Job description

AbbVie is seeking a CDSO Operations Lead to align study teams with program and study strategies. You will coordinate global CDSO study teams, oversee operational lead activities, and connect cross-functional groups to meet objectives.

You will guide analytics-driven execution, ensure regulatory compliance, and mentor data science staff while contributing to process improvements and lessons learned across studies.