Study Start-up Specialist II

About the role

ICON Strategic Solutions is hiring a Study Start-up Specialist II in Guangzhou. 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. The role involves site start-up and activation activities.

Key responsibilities

• Lead the preparation and submission of 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 responsibility for your deliverables and take part in process improvement initiatives to streamline start-up.

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.
• Willingness to travel approximately 5% of the time.
• 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.