Clinical Trials Manager

Role Summary

Leads and manages the operational activities to support planning, initiation, conduct and close out of assigned Clinical Studies (domestic and global studies). Manages studies using Contract Research Organizations (CROs) as well as managing internally run studies.

Responsibilities

• Ensures clinical studies are conducted in compliance with FDA regulations, EU Directive, ICH guidelines, and NBI SOPs and policies
• Serves as primary point of contact for clinical operations aspects of assigned clinical studies
• Participates in technical and study design discussions and provides input to clinical trial outlines, protocols, and clinical study reports
• Manages CROs and other CSPs for assigned studies
• Leads study team meetings and manages study issues. Develops and manages study timelines in accordance with corporate goals. Identifies barriers to enrollment and develops recruitment solutions
• Manages internally run studies (without CROs) including the management of CRAs and develops monitoring plans, on-site monitoring guidelines, forms, tools and performs onsite monitoring and co-monitoring visits, as necessary
• Works collaboratively with the clinical operations department in developing, implementing and enforcing NBI standard processes across all clinical programs
• Other duties as assigned

Qualifications

• BS/BA degree and 6+ years of clinical trial management experience, including CRO/vendor management (domestic and international), monitoring of budget scope, clinical site monitoring or related experience required OR Master‚Äôs and 4+ years of related experience
• Detailed knowledge of the clinical drug development process including ICH, GCPs, FDA regulations, and EU Directive
• Excellent knowledge of clinical operations, specifically conducting clinical studies from start-up through close-out
• Broad trial management protocol and process knowledge
• Strong understanding of the Clinical Research industry and the environments in which it operates
• Ability to identify and organize clinical resources, set objectives and provide clear direction; effective time management
• Leadership ability, typically leads lower levels and/or indirect teams
• Excellent computer skills
• Excellent communications, problem-solving, and analytical thinking skills
• Ability to meet multiple deadlines across projects/programs with high accuracy and efficiency
• Excellent project management skills
• Proven ability to work through others to deliver results to quality and timeline metrics; cross-functional collaboration
• Ability to analyze data to derive conclusions and drive sound decisions
• Knowledge of best practices in the functional discipline and related business disciplines
• Willingness to improve tools and processes within the area
• Developing reputation inside the company as it relates to area of expertise
• Ability to work as part of and lead multiple teams

Skills

• Clinical trial management
• Vendor/CRO management
• Regulatory compliance (FDA, EU, ICH, GCP)
• Project management
• Data analysis and decision making
• Cross-functional collaboration

Education

• BS/BA or Master‚Äôs degree as per qualifications above