Senior Clinical Trials Manager
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Job Description
Sr Clinical Trials Manager providing oversight for international clinical trials at Kite Pharma. Focused on managing budgets and timelines while ensuring compliance with regulatory standards.
Responsibilities:
- Provides guidance and daily oversight for managing all aspects of international clinical trials
- Coaches members of a work team and ensures adherence to established guidelines
- Communicates with functional peers regarding project status and issues
- Contributes to development of abstracts, presentations, and manuscripts
- Provides guidance and training to CROs, vendors, investigators, and study coordinators
Requirements:
- 8+ years of experience
- BS or BA in a relevant scientific discipline OR RN (2 or 3 year certificate)
- Thorough knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials
- Experience in developing RFPs and selection and management of CROs/vendors
- Ability to write study protocols, study reports, sections for investigator brochures, and regulatory documents with little supervision
Benefits:
- Discretionary annual bonus
- Discretionary stock-based long-term incentives
- Paid time off
- Company-sponsored medical, dental, vision, and life insurance plans
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