Study Start-Up Lead — Regulatory & Site Activation

ICON Strategic Solutions; United States; On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Various annual leave entitlements

Health insurance options

Retirement planning offerings

Global Employee Assistance Programme (

Life assurance

Flexible country-specific benefits

Job summary

ICON Strategic Solutions is seeking a Start-Up Lead to drive country-level start-up activities in compliance with ICH-GCP and local regulations. You will manage regulatory documentation, coordinate with CRAs and local study teams, and ensure timely site activation across sponsor partnerships.

The role requires strong project management, excellent communication, and the ability to handle multiple priorities under tight deadlines.

Qualifications

• Bachelor’s Degree, preferably in life sciences.
• Minimum of 5 years of experience in a Clinical Research environment, focusing on Start-Up.
• Strong project management skills, with a deep understanding of regulatory and submission processes
• Excellent written and verbal communication abilities.
• Proven ability to work efficiently to tight deadlines and manage multiple priorities.

Responsibilities

• Lead start-up and regulatory activities at country level ensuring compliance with ICH–GCP and local guidelines.
• Prepare, review, and manage site regulatory documentation; track performance metrics.
• Collaborate with CRAs and Local Study Team to achieve milestones in a timely manner.
• Contribute to feasibility assessments for studies to ensure high quality.
• Submit applications and documents to regulatory authorities and IEC/IRB during start-up.
• Update CTMS and other systems with site data during start-up.
• Ensure essential documents are uploaded into the eTMF per requirements.
• Provide regular updates on milestones and key issues to Line Managers.

Skills

Project management

Regulatory knowledge

Communication skills

Time management

Education

Bachelor’s Degree in life sciences

Tools

CTMS

eTMF

Job description

ICON Strategic Solutions is seeking a Start-Up Lead to drive country-level start-up activities in compliance with ICH-GCP and local regulations. You will manage regulatory documentation, coordinate with CRAs and local study teams, and ensure timely site activation across sponsor partnerships.

The role requires strong project management, excellent communication, and the ability to handle multiple priorities under tight deadlines.