Business Operations Associate - Site and SSU Specialist
LocationJapan, Tokyo
Work modeon-site
Typefull-time
Company size10,000+ people
First seen1w ago
Last seen1d ago
About the role
Site and SSU Specialist - Tokyo - Office
About the company
ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
We are currently seeking a Study Start Up Associate II to join our diverse and dynamic team. As a Study Start Up Associate II 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 inNvative treatments and therapies.
What you will be doing
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Leading the preparation and submission of regulatory documents, including clinical trial applications, ethics committee submissions, and regulatory agency communications.
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Coordinating and liaising with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation.
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Managing and maintaining comprehensive and accurate records of regulatory submissions, approvals, and correspondence
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Providing guidance and support to study teams on regulatory requirements and best practices for study start-up activities.
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Participating in process improvement initiatives to streamline study start-up processes and enhance efficiency