Description
Duties:- 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
- 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
Experience:
- At least 4 years experience in a biotech or pharmaceutical/CRO organization
- Preferred areas of therapeutic expertise; neurology/psychiatry, orphan diseases, and oncology
- 1- 3 years of experience managing direct reports
- Broad knowledge and cross-functional understanding of clinical trial methodology
- Excellent knowledge of and experience with clinical trial documentation, including monitoring requirements, regulations, and operational aspects of clinical trials
- Extensive knowledge of Good Clinical Practices and application to the conduct of clinical studies
- Strong Communication skills; verbal, written, and presentation
- Demonstrated excellence in the following competency areas: Leadership, people management, teamwork and collaboration, organization, and communication
- Financial acumen in creating and managing clinical operations budgets