Description
Responsibilities:- Direct management of Clinical Operations team(s)
- Oversight of operational activities for CROs
- Program-specific leadership, guidance, clinical trial management expertise, and direction to achieve results
- Lead career planning and development activities for direct reports
- Performance management and effective coaching and training to achieve results
- Maintain metrics for Clinical Operations tasks and skills including processes, monitoring, and best practices
- Track data and trends on direct report job satisfaction, retention and productivity
- Recruit top talent and staff appropriates
- Liase with GCP Compliance on audit issues and inspection readiness activities
- Provide input on compliance with BioMarin and Development Sciences policies and procedures
- Assess quality of work for direct reports including monitoring visits, co-monitoring or oversight visits with CROs, data quality, and data clarification form managements, protocol deviation management, and planning and coordination of investigator meetings
- Develop Clinical Operations budget including resource needs and other functional budgets)
- Contribute to improvement of processes, systems, and tools as well as infrastructure within Clinical Operations
- Contribute to project clinical team meetings to provide timely and accurate operational updates, plans and recommendations
- Contribute to the development and review of Clinical Operations SOPs
- Provide input on clinical documents including protocols for content and accuracy
- Participate in standardization of tools within and across Clinical Operations programs
To find out more about Real please visit www.realstaffing.com