Global Study Start-up Lead - Regulatory & Site Activation

ICON Clinical Research; Philadelphia (Philadelphia County); On-site; USD 100,000 - 150,000; Full time

Job summary

ICON Strategic Solutions is seeking a Start-Up Lead in the United States (Philadelphia). You will manage country-level start-up activities, ensure regulatory compliance, and coordinate with CRAs and the Local Study Team to achieve study milestones.

The role requires a life sciences degree and 5+ years in Clinical Research, with strong regulatory knowledge and project management skills. Competitive benefits and career development opportunities are offered.

Qualifications

• Bachelor's degree in life sciences or related field.
• Minimum of 5 years in Clinical Research focusing on Start-Up.
• Strong understanding of regulatory and submission processes.
• Excellent written and verbal communication abilities.

Responsibilities

• Manage start-up activities at country level in compliance with ICH‑GCP and regulations.
• Prepare, review and track site regulatory documentation and milestones.
• Collaborate with CRAs and Local Study Team to meet start-up timelines.
• Maintain site performance metrics and update CTMS with required data.
• Ensure timely collection of essential documents for study start-up and enrollment readiness.
• Report regularly to Line Managers on milestones and key issues.

Skills

Clinical research experience

Project management

Regulatory knowledge

Education

Bachelor's Degree in life sciences

Job description

ICON Strategic Solutions is seeking a Start-Up Lead in the United States (Philadelphia). You will manage country-level start-up activities, ensure regulatory compliance, and coordinate with CRAs and the Local Study Team to achieve study milestones.

The role requires a life sciences degree and 5+ years in Clinical Research, with strong regulatory knowledge and project management skills. Competitive benefits and career development opportunities are offered.