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 SOPs/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 contract service providers for assigned studies
• Leads study team meetings and manages study issues; develops and manages study timelines; identifies barriers to enrollment and develops recruitment solutions
• Manages internally run studies (without CROs) including management of CRAs and development of monitoring plans, on-site monitoring guidelines, forms/tools; performs on-site monitoring and co-monitoring visits as necessary
• Collaborates with the clinical operations department to develop, implement and enforce 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 degree 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 relevant environments
• 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, analytical thinking skills
• Ability to manage multiple deadlines across projects/programs with accuracy and efficiency
• Excellent project management skills
• Proven ability to work through others to deliver results with quality and on schedule; ability to partner cross-functionally and with customers
• Proven ability to analyze data to derive conclusions and drive decision making
• Knowledge of best practices in the functional discipline
• Experience improving tools and processes within the functional 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 operations management
• Vendor/CRO management
• Project management
• Regulatory compliance (FDA, ICH/GCP, EU Directive)
• Data-driven decision making
• Cross-functional collaboration

Education

• Bachelor‚Äôs degree required; Master‚Äôs degree preferred