The Study Start-Up Lead plans and executes global SSU activities to ensure timely trial document and task completion to enable country HA and Ethics Committee submissions and site activation to meet ambitious recruitment plans
Job Summary
The Study Start-Up Lead plans and executes global SSU activities to ensure timely trial document and task completion to enable country HA and Ethics Committee submissions and site activation to meet ambitious recruitment plans.
Key accountabilities include early planning and team leadership, contributing SSU insights to the development of the trial Operational Execution Plan, and preparing global SSU planning.
The role provides oversight and support to country Study Start-up Managers to ensure study start-up activities are conducted and completed to plan, and ensures global deliverables are in place for site initiation readiness.
Matching Summary
The Study Start-Up Lead plans and executes global SSU activities to ensure timely trial document and task completion to enable country HA and Ethics Committee submissions and site activation to meet ambitious recruitment plans.
Salary
Base: zł195,700.00 - zł363,400.00; Bonus/Equity: Not specified; Benefits: Not specified
Skills & Requirements
Must-have
Study Start-Up planning
global SSU activities
Health Authorities submissions
Ethics Committee submissions
site activation
GCP and ICH guidelines
Nice-to-have
high learning agility
influencing and negotiation
championing innovative technology
Key Requirements
Bachelor's Degree in Life sciences
6 years clinical research experience
3 years leadership capacity experience
Thorough understanding of regulated clinical trial environment