Clinical Data Strategy & Operations Lead I

AbbVie Inc.; Irvine (CA); On-site; USD 120,000 - 190,000; Full time

Job summary

AbbVie is seeking a senior professional to lead Clinical Data Strategy and Operations, coordinating cross-functional teams to align study-level objectives with program strategies. This role emphasizes governance, analytics, and regulatory compliance in trial delivery.

The position requires solid experience in pharma/clinical research, strong PM skills, and the ability to influence without direct authority. A master’s degree and professional certifications are preferred.

Qualifications

• Bachelor’s degree in business, MIS, CS, life sciences or equivalent; Master’s preferred.
• PMP Certification or Lean Six Sigma Green Belt desirable
• 3+ years pharma/clinical research/data management or 5+ years project management experience
• Strong understanding of clinical trial process and clinical technology
• Experience managing a clinical trial from initiation through completion is preferred
• Demonstrated leadership and ability to influence others without direct authority
• Demonstrated effective communication and analytical skills

Responsibilities

• Align CDSO study teams with program- and study-level strategies.
• Act as single operational lead from CDSO and coordinate cross-functional study teams.
• Engage and influence cross-functional team members to meet objectives.
• Use operational analytics and project management tools to optimize execution and track progress.
• Ensure adherence to GCPs, ICH guidelines, and AbbVie SOPs.
• Oversee vendors and provide feedback on performance.
• Mentor Data Science Associates; may supervise contract resources.
• Contribute to CDSO and cross-functional process improvement initiatives.
• Capture and share study execution lessons learned across functions.

Skills

Pharma/clinical research experience

Project management

Leadership

Influence without authority

Communication skills

Analytical skills

Education

Bachelor’s degree in business, MIS, CS, life sciences or equivalent

Master’s degree preferred

PMP or Lean Six Sigma Green Belt desirable

Job description

AbbVie is seeking a senior professional to lead Clinical Data Strategy and Operations, coordinating cross-functional teams to align study-level objectives with program strategies. This role emphasizes governance, analytics, and regulatory compliance in trial delivery.

The position requires solid experience in pharma/clinical research, strong PM skills, and the ability to influence without direct authority. A master’s degree and professional certifications are preferred.