Impactful Clinical Data Strategy & Ops Lead I

AbbVie Inc.; Chicago (IL); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Benefits package

401(k) plan

Paid time off

Job summary

AbbVie is seeking a Clinical Data Strategy and Operations leader in Chicago to align study teams with program strategies and drive operational excellence across studies. You will partner with global, cross-functional teams, manage vendors, and mentor data science associates while ensuring regulatory compliance and high-quality execution.

The role requires 3+ years in pharma/clinical data or 5+ years in project management, with strong leadership and communication skills.

Qualifications

• Must have 3+ years of pharma / clinical research / data management / health care experience or 5+ years of project management experience (and / or applicable work experience).
• Strong understanding of clinical trial process and clinical technology. Experience in managing a clinical trial from initiation through to completion is preferred.
• Demonstrated effective leadership skills.
• Demonstrated ability to influence others without direct authority.
• Demonstrated effective communication skills.
• Demonstrated effective analytical skills.

Responsibilities

• Aligns CDSO study teams with program- and study-level strategies. For assigned studies, leads the CDSO Study Team and represents CDSO as a member of the cross-functional study team
• For assigned studies, acts as single point of contact and accountable operational lead from CDSO. Coordinates associated CDSO study teams to meet operational objectives. Engages and connects global functional and cross-functional teams
• Interacts with and influences cross-functional team members to achieve program and study objectives
• Utilizes operational analytics and project management tools to optimize execution of programs and studies, to manage internal and external resources, to track study progress, and to prepare study status reports. Anticipates and identifies issues that could affect timelines or quality and develops options and solutions
• Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and to functional quality standards. Stays abreast of new and/or evolving local regulations, guidelines and policies related to clinical development
• Participates in oversight of vendors and provides feedback related to study operations, issues, and trends in performance
• Responsible for coaching and mentoring Data Science Associates. May include indirect supervision of work for contract resources
• Participates in CDSO and cross-functional innovation and process improvement initiatives
• Contributes to study execution “lessons learned” across functions

Education

Bachelors degree in business, management information systems, computer science, life sciences or equivalent. Masters preferred. PMP Certification or Lean Six Sigma Green Belt desired

Job description

AbbVie is seeking a Clinical Data Strategy and Operations leader in Chicago to align study teams with program strategies and drive operational excellence across studies. You will partner with global, cross-functional teams, manage vendors, and mentor data science associates while ensuring regulatory compliance and high-quality execution.

The role requires 3+ years in pharma/clinical data or 5+ years in project management, with strong leadership and communication skills.