US Study Start Up Lead
Core
Lead operational strategy and management of start-up activities for all clinical trials across multiple therapy areas, ensuring timely site activation and regulatory compliance.
Role type
Senior clinical trial operations lead (study start-up)
Builds
Clinical trial study start-up processes and site activation timelines
Domain
Pharmaceutical industry, clinical research
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical operations, ICH-GCP, regulatory processes, site selection, feasibility analysis, project management, budget control, stakeholder coordination
Preferred skills
Matrix team leadership, performance indicator monitoring, informed consent review, process optimization
Technologies
AI-enabled tools, digital solutions for clinical trial operations
Responsibilities
Ensure timely start-up of clinical studies to agreed timelines and metrics; coordinate between central, global, and within-country study teams; maintain internal tracking for site status from contact through initiation; deliver country feasibility, site selection, and recruitment planning; prepare and track regulatory documentation including ethics submissions; optimize start-up processes and share best practices.
Seniority
Senior, hands-on IC with strategic oversight
