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gcpproject managementlean six sigmaclinical trialsdatapmpregulatoryich guidelinescdso
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Job Description
📋 Description
- Lead CDSO Study Team; represent DS on cross-functional study teams.
- Coordinate CDSO study teams to meet operational objectives; engage cross-functional teams.
- Influence cross-functional members to achieve program and study objectives.
- Use operational analytics and PM tools to optimize program execution and track progress.
- Ensure adherence to GCP, ICH guidelines, AbbVie SOPs, and local regulations.
- Mentor Data Science Associates; may oversee contract resources.
🎯 Requirements
- Bachelor’s degree in business, MIS, CS, life sciences; Master’s preferred; PMP or Lean Six Sigma
- 3+ years pharma/clinical data management or 5+ years PM experience
- Strong understanding of clinical trial processes and technology
- Proven leadership and ability to influence without authority
- Strong communication and analytical skills
🎁 Benefits
- Competitive compensation and benefits package
- Paid time off; medical/dental/vision insurance; 401(k)
- Short-term incentive programs