Opening Headline Study Start Up Associate II (Supporting North America region - US/CAN)At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s integral expertise.

As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

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.

What You Will Do:
You will contribute to site start-up and activation activities, taking responsibility for your deliverables and working collaboratively.

Key responsibilities include:
- 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:
You will bring relevant site start-up and activation experience, along with the following qualifications and skills.

Required qualifications and experience:
- 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 regulator

📌 Study Start Up Associate II (Ciudad de México)
🏢 IRE
📍 Ciudad de México