Clinical Research Associate Manager
Description:
• Oversight of CRA performance, development and coaching of CRA
• Managing and addressing CRA performance targets per defined KPIs: delivery, productivity, and quality performance indicators
• Monitoring and approving CRA travel and expense to ensure compliance to T&E policy
• Ensures CRA monitoring competency gaps are identified and resolved through targeted coaching and training curricula
• Liaise on ongoing basis with CPMs to ensure enrollment, data collection and data cleaning are executed by CRAs in a timely manner
Requirements:
• 4-year degree plus relevant, related healthcare experience
• Minimum 7 years’ experience in clinical research -planning/executing and/or monitoring clinical trials
• Field Monitoring experience
• Leadership experience
• Experience in project management and evidence of team leadership capabilities
• Understanding of all aspects of clinical drug development with particular emphasis on monitoring and trial execution
• Thorough understanding of the international aspects of drug development process, including expert knowledge of international standards (GCP/ICH), health authorities (FDA/EMA), local/National Health Authorities regulations, risk-based monitoring and Novartis standards
Benefits:
• health
• life and disability benefits
• 401(k) with company contribution and match
• generous time off package including vacation, personal days, holidays and other leaves
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