Business Operations Associate - Site and SSU Specialist
ICON plc · Tokyo
Site and SSU Specialist - Tokyo - OfficeICON 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