Site Start-up Specialist II

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON's global expertise.

As a Study Start Up Associate II at ICON, you will lead the initiation of clinical trials, ensuring compliance with regulatory requirements, and contribute to the advancement of innovative treatments and therapies.

Responsibilities:

• Leading the preparation and submission of regulatory documents, including clinical trial applications, ethics committee submissions, and regulatory agency communications.
• Coordinating and liaising with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation.
• Managing and maintaining comprehensive and accurate records of regulatory submissions, approvals, and correspondence.
• Providing guidance and support to study teams on regulatory requirements and best practices for study start-up activities.
• Participating in process improvement initiatives to streamline study start-up processes and enhance efficiency.

Your 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 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%).

Rewards & Benefits:

• 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.