Study Start Up Associate II (US/Canada)

About the role

ICON Strategic Solutions is hiring a Study Start Up Associate II with North American experience (United States and Canada). Working in a sponsor-dedicated model, you will lead the initiation of clinical trials, ensure compliance with regulatory requirements and help advance treatments that benefit patients worldwide.

Key responsibilities

• Lead site start-up and activation activities, taking responsibility for your deliverables
• Prepare and submit regulatory documents, including clinical trial applications, ethics committee submissions and regulatory agency communications
• Coordinate with internal and external stakeholders to obtain the approvals and authorisations needed for study initiation
• Maintain accurate records of regulatory submissions, approvals and correspondence
• Support study teams on regulatory requirements and best practices for study start-up
• Take part in process improvement initiatives to streamline start-up processes

Required profile

• Bachelor's degree in life sciences or a related field
• Minimum of 2 years of experience in clinical research or regulatory affairs, with specific experience in study start-up
• Demonstrated experience in ethics submissions and managing the ethical review process for clinical studies at U.S. study sites (the role supports the North America region)
• Legal right to work in the country where the role is based

Required skills

• Strong understanding of regulatory requirements and guidelines, including ICH-GCP and local regulations
• Organizational and project management skills, able to handle multiple tasks at once
• Communication and collaboration skills with cross-functional teams

What we offer

• Competitive base salary and performance-related incentives
• Health and wellbeing programmes, including medical, dental and vision coverage where applicable
• Retirement and pension plans, life assurance and disability coverage
• Employee assistance programmes and learning and development opportunities