Director, Site Start Up
Core
Provides leadership to the Site Start-up (SSU) department, driving strategy, expansion, and delivery of clinical trial initiation activities including regulatory submissions and contract negotiations.
Role type
Senior management clinical research director (site start-up)
Builds
Clinical trial site initiation services for pharmaceutical and biotech clients
Domain
Clinical Research / Life Sciences
Deliverable
client delivery
Required skills
Strategic planning, regulatory compliance (GCP/ICH), team leadership, risk management, change management, budget negotiation, process optimization
Preferred skills
Resource management, stakeholder management, business development collaboration, KPI development
Technologies
CTMS, eTMF, EDC, Microsoft Office
Responsibilities
Lead SSU team and project delivery, manage regulatory submissions (IRB/EC/CA), oversee site contract negotiations, optimize SSU processes for profitability, support business development proposals, develop and report SSU KPIs
Seniority
Director, strategic leadership & team management
