Study Start-up Lead
ICON · Cary, NC +1 more
Clinical OperationsFull-timeCompany career page
The apply link worked recently (not employer-confirmed).
Role summary
Lead clinical study start-up activities at country level for a global contract research organization. Manage regulatory documentation, site activation, and compliance with ICH-GCP guidelines while collaborating with clinical teams to meet study milestones efficiently.
What they're looking for
- Bachelor's degree, preferably in life sciences
- Minimum 5 years clinical research experience focused on study start-up
- Strong project management and regulatory submission process knowledge
- Excellent written and verbal communication skills
- Ability to manage multiple priorities and meet tight deadlines
- Legal right to work in the country where role is based
What you'll be doing
- Prepare, review, and track site regulatory documentation and essential trial documents
- Manage regulatory submissions to authorities and institutional review boards during start-up
- Maintain and report on site performance metrics and study milestone achievement
- Update clinical trial management systems with site data according to required timelines
- Coordinate with clinical research associates and local study teams to resolve outstanding actions
Privacy & handoff
This role links to ICON's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.