Responsibilities:
- Align DSS study teams with program- and study-level strategies; lead the DSS Study Team and represent Data Science on cross-functional study teams
- Serve as single point of contact and accountable operational lead from DSS; coordinate DSS study teams to meet operational objectives and connect global functional/cross-functional teams
- Interact with and influence cross-functional team members to achieve program and study objectives
- Use operational analytics and project management tools to optimize program/study execution, manage internal/external resources, track progress, prepare status reports; anticipate and resolve issues affecting timelines/quality
- Ensure adherence to federal/local regulations, GCPs, ICH Guidelines, AbbVie SOPs, and functional quality standards; stay current on evolving regulations/guidelines
- Participate in oversight of vendors and provide feedback on study operations, issues, and performance trends
- Coach and mentor Data Science Associates; may include indirect supervision for contract resources
- Participate in DSS and cross-functional innovation and process improvement initiatives
- Contribute to cross-functional “lessons learned” for study execution
Qualifications:
- Bachelor’s degree in business, management information systems, computer science, life sciences, or equivalent; Master’s preferred; PMP Certification or Lean Six Sigma Green Belt desired
- 3+ years of pharma/clinical research/data management/health care experience or 5+ years of project management experience (or applicable work experience)
- Strong understanding of clinical trial process and clinical technology; experience managing a clinical trial from initiation to completion preferred
- Demonstrated leadership, communication, influence without direct authority, and analytical skills