Study Start-up Specialist II

About the role

ICON Strategic Solutions is hiring a Study Start-up Specialist II in Beijing. 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 sits within ICON's global network of more than 90 sponsor partnerships.

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
• 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 clinical trial regulatory requirements, 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