Responsibilities:
- Align DSS study teams with program- and study-level strategies; lead the DSS Study Team for assigned studies and represent Data Science within cross-functional study teams.
- Act as single point of contact and accountable operational lead from DSS for assigned studies; coordinate DSS study teams to meet operational objectives; engage global functional and 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 execution, manage internal/external resources, track study progress, prepare study status reports; anticipate/identify issues affecting timelines or quality and develop options/solutions.
- Ensure adherence to federal/local regulations, GCPs, ICH guidelines, AbbVie SOPs, and functional quality standards; stay current on evolving regulations/policies related to clinical development.
- Participate in vendor oversight; provide feedback on study operations, issues, and performance trends.
- Coach and mentor Data Science Associates; may include indirect supervision of contract resources.
- Participate in DSS and cross-functional innovation and process improvement initiatives.
- Contribute to study execution “lessons learned” across functions.
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/healthcare experience OR 5+ years of project management experience (and/or applicable work experience).
- Strong understanding of clinical trial process and clinical technology; experience managing a clinical trial from initiation through completion preferred.
- Demonstrated effective leadership, ability to influence without direct authority, communication, and analytical skills.