Clinical Research Associate Manager @ Novartis
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Summary
The Clinical Research Associate Manager at Novartis is responsible for the oversight of CRA performance, development, and coaching to drive mindset and behavior. This role focuses on achieving performance targets related to delivery, productivity, and quality by managing site recruitment commitments, timely data entry, and issue resolution.
People and Resource Management
Manage and assess allocation of CRAs to studies and sites. Drive team performance through development and performance improvement plans.
Budget Oversight
Monitor and approve CRA travel and expenses to ensure compliance with T&E policy and meet local budget targets.
Training and Competency
Identify competency gaps and resolve them through targeted coaching, co-monitoring visits, and collaboration with training groups.
Collaboration
Liaise with Clinical Project Managers to ensure timely enrollment, data collection, and data cleaning.
Key Responsibilities
- Monitor data quality and ensure issue resolution
- Implement annual oversight visit plans
- Conduct co-monitoring visits for training purposes
- Manage travel budgets and expense reports
- Support audits, inspections, and CAPA follow-ups
Essential Requirements
- 4-year degree plus relevant healthcare experience
- Minimum 7 years’ clinical research experience
- Field monitoring and leadership experience
- Expertise in clinical drug development and international standards (GCP/ICH, FDA/EMA)
Desirable Requirements
- Advanced degree
- Experience managing and leading a team of CRAs
Additional Information
This position is remote within the U.S. and requires 80% travel. Applicants must have a valid driver's license. Novartis offers competitive salary and benefits packages including performance-based incentives, equity awards, and comprehensive benefits.
Key Skills/Competency
- CRA Performance
- Coaching
- Team Leadership
- Resource Management
- Budget Oversight
- Clinical Research
- Data Quality
- Regulatory Compliance
- Training
- Audit Support
How to Get Hired at Novartis
🎯 Tips for Getting Hired
- Customize Your Resume: Highlight clinical research and leadership experience.
- Research Novartis: Understand their culture, values, and recent news.
- Showcase Relevant Skills: Emphasize project management and trial oversight.
- Prepare for Interviews: Practice questions on compliance and team leadership.