We are currently seeking a Study Start Up Associate to join our diverse and dynamic team. As a Study Start Up Associate at ICON, you will play a pivotal role in leading the initiation of clinical trials, ensuring compliance with regulatory requirements, and contributing to the advancement of inNovative treatments and therapies.

What you will be doing

• 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 4 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.