Clinical Trials Manager

Role Overview

• Coordinating and supervising all aspects of a clinical study
• Monitors clinical trial sites
• Assists Clinical Program Manager in overall study management
• Drafts and coordinates review of relevant documents including protocols, informed consents, case report forms, monitoring plans, investigator brochures, and clinical study reports
• Maintains study timelines
• Contributes to development of study budget
• Contributes to development of RFPs and participate in selection of CROs/vendors
• Manage CROs/vendors
• Coordinates review of data listings and preparation of interim/final clinical study reports
• May contribute to development of abstracts, presentations, and manuscripts
• Ensures effectiveness of site budget/contract process
• May be asked to train CROs, vendors, investigators, and study coordinators on study requirements

Requirements

• Bachelor's Degree and 5 Years' Experience OR Masters' Degree and 3 Years' Experience
• Thorough knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials
• Must have general, functional expertise to support SOP development and implementation
• 6+ years of experience and an RN (2 or 3 year certificate) preferred

Benefits

• company-sponsored medical, dental, vision, and life insurance plans*
• discretionary annual bonus
• discretionary stock-based long-term incentives (eligibility may vary based on role)
• paid time off