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 execution, manage resources, track progress, prepare status reports; anticipate issues impacting timelines/quality and develop options/solutions.
- Ensure adherence to federal/local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie SOPs, and functional quality standards; stay current on evolving local regulations/guidelines for clinical development.
- Participate in vendor oversight and 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; contribute to study execution “lessons learned.”
Qualifications:
- Bachelor’s 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 pharma/clinical research/data management/health care experience or 5+ years project management experience (and/or relevant work experience).
- Strong understanding of clinical trial process and clinical technology; experience managing a trial from initiation to completion preferred.
- Demonstrated leadership, ability to influence without authority, communication, and analytical skills.
Benefits:
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, 401(k) to eligible employees; eligible for short-term incentive programs.