Study Start Up Associate II

About the role

ICON is a global healthcare intelligence and clinical research organisation. As a Study Start Up Associate II, you will lead the initiation of clinical trials, ensure compliance with regulatory requirements and help advance new treatments and therapies. The role is office or home based, with approximately 5% travel required.

Key responsibilities

• Contribute to site start-up and activation activities, taking responsibility for your deliverables
• 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 approvals and authorisations 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
• At least 2 years of experience in clinical research or regulatory affairs, with specific experience in study start-up
• Fluency in English and your local language, plus Italian, Dutch or a Nordic language
• Willingness to travel as required (about 5%)
• 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 several tasks at once
• Communication and interpersonal skills, working 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