Business Operations Associate - Site and SSU Specialist

Site and SSU Specialist - Tokyo - Office

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

• 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

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include

• 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

• Benefits may vary depending on role and location.
• Visit our careers site to read more about the benefits ICON offers.

Inclusion and Accessibility

• ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
• If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.
• Are you a current ICON Employee? Please click here to apply