Study Start Up Associate II

• Lead the initiation of clinical trials, ensuring compliance with regulatory requirements
• Contribute to site start-up and activation activities, taking responsibility for deliverables and working collaboratively
• Lead the preparation and submission of regulatory documents, including clinical trial applications, ethics committee submissions, and regulatory agency communications
• Coordinate and liaise with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation
• Manage and maintain comprehensive and accurate records of regulatory submissions, approvals, and correspondence
• Provide guidance and support to study teams on regulatory requirements and best practices for study start-up activities
• Participate in process improvement initiatives to streamline study start-up processes and enhance efficiency

• 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 activities
• Strong understanding of regulatory requirements and guidelines for clinical trials, including ICH-GCP and local regulatory requirements
• Excellent organizational and project management skills, with the ability to prioritize and manage multiple tasks simultaneously
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams
• Willingness to travel as required (approximately 5%)
• Employment with ICON is contingent upon having the legal right to work in the country where the role is based

• 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 wellbeing resources
• Learning and development opportunities through structured training and career pathways