Clinical Trial Manager (CTM)

Nurix•Brisbane, CA

4d•Onsite

About The Position

This individual is responsible for the management of assigned clinical trial(s), leading the study team, vendors, clinical monitors, and clinical sites throughout the trial lifecycle. The Opportunity Own all operational aspects of your assigned clinical trial(s) Manage day-to-day CRO/vendor relationships to keep deliverables on budget, timeline, and protocol Build strong working relationships with site investigators and study coordinators Track trial progress and keep stakeholders updated on status Monitor enrollment and address recruitment challenges as they arise Manage study budget, forecasting, accruals, and vendor payments for your trial(s) Partner with Data Management on CRF content, completion guidelines, and data deliverables Draft and coordinate review of protocols, informed consents, CRFs, monitoring plans, and study reports Prepare for and support regulatory agency audits and inspections Flag risks early and recommend solutions before they become problems Represent Clinical Operations at project team meetings

Requirements

S./B.A. in biological sciences with 5+ years of relevant industry experience
Ability to travel as required for the program (25%)
Working knowledge of FDA, EMA, ICH, and GCP regulations and guidelines
Experience managing trials independently from start-up through close-out
Comfortable leading day-to-day CRO/vendor relationships
Strong analytical and problem-solving skills
Clear, confident communicator who can create direction for a study team
Ability to manage time demands, incomplete information, and shifting priorities
Highly organized, able to multi-task and prioritize independently
Thrives in a fast-paced, small-company environment

Responsibilities

Own all operational aspects of your assigned clinical trial(s)
Manage day-to-day CRO/vendor relationships to keep deliverables on budget, timeline, and protocol
Build strong working relationships with site investigators and study coordinators
Track trial progress and keep stakeholders updated on status
Monitor enrollment and address recruitment challenges as they arise
Manage study budget, forecasting, accruals, and vendor payments for your trial(s)
Partner with Data Management on CRF content, completion guidelines, and data deliverables
Draft and coordinate review of protocols, informed consents, CRFs, monitoring plans, and study reports
Prepare for and support regulatory agency audits and inspections
Flag risks early and recommend solutions before they become problems
Represent Clinical Operations at project team meetings