Associate Director, Clinical Operations Program Lead, Study Start-up & Feasibility
Core
Lead strategy and implementation of country and site feasibility and study start-up for clinical trials in rare diseases.
Role type
Senior management clinical operations program lead (study start-up & feasibility)
Builds
Feasibility strategies, start-up plans, and oversight models for clinical studies
Domain
Biopharmaceuticals / Clinical Research / Rare Diseases
Required skills
Clinical trial feasibility, Study start-up management, CRO oversight, Budget planning, Protocol/ICF development, Regulatory knowledge (ICH/GCP), Team leadership, KPI reporting
Preferred skills
Rare disease population experience, Feasibility questionnaire development, Multi-vendor management
Technologies
CTMS, PowerPoint
Responsibilities
Develop feasibility and start-up strategies, Manage integrated timelines and report progress, Lead meetings with study leads and CROs, Oversee investigator selection, Mentor junior team members, Create reporting tools for KPIs
Seniority
Associate Director, hands-on leadership with direct reports