Study Start-up Lead

ICON is hiring a Study Start-up Lead to manage country-level study initiation activities, regulatory documentation, and site activation in compliance with ICH-GCP guidelines and local regulations. The role involves coordinating with clinical research associates and local teams to ensure timely achievement of study milestones.

Responsibilities

• Manage collection, preparation, review, and tracking of site regulatory documentation at country and site level
• Submit applications and documents to regulatory authorities and IEC/IRB during study start-up
• Maintain and report on site performance metrics and clinical/operational feasibility assessments
• Coordinate with clinical research associates and local study teams to achieve start-up milestones efficiently
• Ensure timely collection and verification of essential documents in eTMF per ICH-GCP requirements

Requirements

• Bachelor's degree, preferably in life sciences
• Minimum 5 years clinical research experience with focus on study start-up
• Strong project management skills and regulatory submission process knowledge
• Excellent written and verbal communication abilities
• Ability to work efficiently under tight deadlines and manage multiple priorities
• Legal right to work in the country where role is based