Study Start Up Associate II - Clinical Trials

About the role

ICON, a global healthcare intelligence and clinical research organisation, is looking for a Study Start Up Associate II to join its Tokyo office. You will lead the initiation of clinical trials, ensure compliance with regulatory requirements and help advance new medicines and treatments.

Key responsibilities

• Lead the preparation and submission of regulatory documents, including clinical trial applications, ethics committee submissions and communications with regulatory agencies
• 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 with guidance on regulatory requirements and best practices for study start-up
• Take part in process improvement initiatives to streamline study start-up

Required profile

• Bachelor's degree in life sciences or a related field
• At least 2 years of experience in clinical research or regulatory affairs, including study start-up
• Strong understanding of clinical trial regulations, including ICH-GCP and local requirements
• Ability to prioritise and manage several tasks at once, and to work with cross-functional teams
• Legal right to work in the country where the role is based

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