Business Operations Associate - Site and SSU Specialist

Site and SSU Specialist - Tokyo - Office

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

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

• 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
• 治験申請書、IRB提出資料、規制当局へのコミュニケーション文書など、規制関連文書の作成・提出を主導する
• 治験開始に必要な承認・許可を得るため、社内外ステークホルダーとの調整および連携を行う
• 規制当局への提出物、承認、関連文書の正確かつ包括的な記録を管理する
• 規制要件および治験開始のベストプラクティスについて、スタディチームへ指導・サポートを提供する
• 治験開始プロセスの効率化に向けた改善活動に参加し、業務の最適化を推進する

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.
• ライフサイエンス関連分野の学士号
• 治験または薬事関連業務で 2 年以上の経験があり、とくに治験開始（Study Start-Up）業務の経験を有する方
• ICH-GCP および各国の規制要件など、治験に関する規制の深い理解
• 優れた組織力・プロジェクトマネジメント能力を持ち、複数タスクを同時に管理できること
• クロスファンクショナルチームと効果的に協働できる、優れたコミュニケーション能力および対人スキル

What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply