Clinical Data Strategy & Operations Program Lead II

Summary

Join AbbVie's Data Science team, a best-in-class group responsible for leveraging clinical trial data to generate business value. This key role ensures successful delivery of program and study accountabilities within Data and Statistical Sciences. You will align study teams with program strategies, act as a single point of contact for operational leadership, and collaborate with cross-functional teams. Responsibilities include optimizing program execution, ensuring regulatory compliance, overseeing vendors, coaching team members, and leading innovation initiatives. The ideal candidate possesses a Bachelor's degree (Master's preferred) and significant experience in pharma/clinical research or project management, along with strong leadership and communication skills. Remote work is possible.

Requirements

• Have a Bachelor’s degree in business, management information systems, computer science, life sciences or an equivalent
• Have 6+ years of pharma / clinical research / data management / health care experience or 8+ years of project management experience (and / or applicable work experience)
• Demonstrate in-depth understanding of clinical trial processes and clinical technology
• Demonstrate performance as a functional leader
• Demonstrate ability to influence others without direct authority
• Demonstrate ability to successfully coach / mentor in a matrix environment
• Demonstrate effective communication skills
• Demonstrate effective analytical skills

Responsibilities

• Align DSS study teams with program- and study-level strategies. Assigned programs may include programs that are of low complexity and size
• For assigned programs and studies, lead the DSS Study Team and represent DS as a member of the cross-functional study team
• For assigned programs and studies, act as single point of contact and accountable operational lead from DSS
• Coordinate associated DSS study teams to meet operational objectives
• Engage and connect global functional and cross-functional teams at the study level
• Interact with and influence cross-functional team members to achieve program objectives
• Utilize 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
• Anticipate and identify issues that could affect timelines or quality and develop options and solutions
• Ensure adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and to functional quality standards
• Stay abreast of new and/or evolving local regulations, guidelines and policies related to clinical development
• If assigned, participate as the DS study owner in regulatory inspections and internal quality audits
• Participate in oversight of vendors and provide feedback related to clinical trial operations, issues, and trends in performance
• Be responsible for coaching and mentoring team members
• Lead DSS innovation and process improvement initiatives and participate in cross-functional initiatives
• Conduct study execution “lessons learned” across functions
• May include indirect supervision of employee as well as supervision of work of contract resources

Preferred Qualifications

• Have a Master’s degree
• Have PMP Certification or Lean Six Sigma Green Belt
• Have managed a clinical trial from initiation through to completion in a lead role

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k)
• Short-term incentive programs
• Long-term incentive programs