[Hiring] Business Operations Associate - Site and SSU Specialist @ICON plc

Role Description

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 innovative treatments and therapies.

• 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。

Qualifications

• 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。

Benefits

• 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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others.