Sr. Specialist, Clinical Trials Operations

Role Summary

Sr. Specialist, Clinical Trials Operations leads centralized operational activities for assigned clinical studies, including study setup, development of Informed Consent documents and study plans, handling IRB submissions, TMF management, site feasibility and selection, committee coordination, site enrollment support, and oversight of monitoring for CRO-led studies.

Responsibilities

• Ensures centralized activities for clinical studies are conducted in compliance with FDA regulations, EU Directives, ICH guidelines, and NBI SOPs/policies
• Collaborates with study teams to develop, implement, and standardize processes across clinical programs
• Supports best practices and improved operational processes for clinical trial execution
• Assists in developing processes, tools, templates, and training related to centralized activities and monitoring oversight
• Generates metrics/reports to provide insights into cycle times for centralized activities and outsourced monitoring
• Documents standard processes across assigned programs and may train lower-level specialists
• Supports inspection readiness activities
• Other duties as assigned

Qualifications

• BS/BA in scientific field or equivalent with 4+ years of clinical trials/operations experience; CRO/vendor management exposure preferred; participation in monitoring clinical trials required (or)
• Master's degree in scientific field or equivalent with 2+ years of relevant experience
• Strong knowledge of the clinical drug development process, ICH, GCPs, FDA regulations, and EU Directives
• Solid understanding of clinical operations from start-up through close-out
• Trial management protocol and process understanding
• Strong understanding of the Clinical Research industry and related environments
• Ability to design, plan, and execute activities; works well under changing circumstances
• Knowledge of best practices in the functional discipline and related business concepts
• Ability to improve tools and processes within the functional area
• Team-oriented with potential to train lower-level staff
• Excellent computer skills
• Strong communication, problem-solving, analytical thinking
• Ability to meet multiple deadlines with accuracy and efficiency
• Strong project management skills
• Ability to analyze data to derive options/recommendations for management

Education

• As specified in Qualifications (BS/BA or Master‚Äôs in scientific field or equivalent)