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 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
• Must have detailed knowledge of clinical drug development process including working knowledge of 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 Clinical Research industry and the relevant environments in which it operates
• Ability to identify and organize clinical resources needed to accomplish tasks, set objectives and provide clear direction to others; experience planning activities in advance and taking account of possible changing circumstances; manages time effectively
• Exhibits leadership skill and ability, typically leads lower levels and/or indirect teams
• Excellent computer skills
• Excellent communications, problem-solving, analytical thinking skills
• Sees broader picture, impact on multiple departments/divisions
• Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
• Excellent project management skills
• Proven ability to work through others to deliver results to the appropriate quality and timeline metrics, monitoring/managing performance and providing feedback; experience productively partnering cross functionally and with customers to advance work effectively and efficiently
• Proven ability at analyzing data and information to derive conclusions and drive sound decision making
• Has knowledge of best practices in the functional discipline and familiarity with the broader underlying concepts of related business disciplines
• Works to improve tools and processes within functional area
• Developing reputation inside the company as it relates to area of expertise
• Ability to work as part of and lead multiple teams

Education

• Not specified beyond degree requirements in qualifications