Site Specialist II

Site Specialist II Japan Tokyo or Osaka

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

Role Summary:

Support preparation, process and tracking of regulatory and site level critical documents and of site activation tasks required for study site activation in accordance with ICON SOPs/WPs, Sponsor SOPs, applicable regulations/guidelines and the principles of ICH/GCP. Embrace and contribute to ICON’s culture of quality and process improvement with a focus on enhancing processes, systems and tools, adding value to our business and meeting or exceeding client needs.

Responsibilities:

• Work with Site Partners and internal key stakeholders to optimize study performance and collaborate to ensure successful site activation and project outcomes.
• Support Site Partners on complex or on program of studies to proficiently collect, review, organize and assemble regulatory initial start-up and maintenance submission packages to Central EC/IRB, Local EC/IRB, Competent Authorities, any other local regulatory authorities as required by countries and in accordance with ICH/GCP and applicable country regulations/guidelines.
• Support collection and assembling of all documents needed in the Critical Document Package (CDP) and of those required for site activation, ensuring that Sponsor and Investigator obligations are being met and are in compliance with applicable requirements and ICH/GCP guidelines.
• Ensure accuracy and completeness of the Critical Document Package according to CDP checklists and timely update of the required tracking tools.
• Support coordination of all necessary translations required for any start-up documentation.
• Proficient in timely and accurate progress data entry of all documents collected from sites and relevant study site activation activities into the appropriate tracking systems and tools and oversee that the site activation tasks are executed according to site activation requirements.
• Accurately forecast Site Activation plans and ensure they are reflected accurately in ICON’s systems, proactively follow through for achievement to plan.
• Contribute to effective site activation process and timelines: participate to internal study review meetings with study teams to contribute and support risk identification to site activation, mitigation and action planning.
• Ensure accuracy and timely completeness of Trial Master File (TMF) documents submitted during start-up and perform a Quality Control (QC) review of files before transfer to maintenance for filing in TMF.

What you need:

• Bachelor’s Degree
• 3-6 years of experience in a Clinical Research environment
• Demonstrate good organizational skills, ability to prioritize tasks and to deal with competing priorities
• Good computer and Microsoft office knowledge
• Completes tasks independently on time and in an efficient manner.
• Ability to support other Site Specialists as needed.
• Demonstrate ability to deal with internal stakeholders.
• Demonstrate ability to identify study and site risks and properly document in tracking and reporting tools; support action planning with other study team stakeholders.

■ 役割概要

ICONのSOP/WP、スポンサーSOP、関連法規・ガイドライン、ICH/GCPの原則に従い、治験施設の立ち上げに必要な規制関連および施設レベルの重要書類の準備、手続き、管理、進捗追跡をサポートします。
品質向上やプロセス改善に積極的に取り組み、システム・ツールの最適化を図りながら、ビジネスの付加価値向上とクライアントニーズの達成に貢献していただきます。

■ 主な業務内容

• 治験施設パートナーおよび社内関係者と連携し、試験の効率的な実施と施設立ち上げの成功をサポート

• 複雑な治験や複数試験プログラムにおいて、規制当局（中央倫理審査委員会（EC/IRB）、現地EC/IRB、各国主管当局等）への初期申請・維持申請書類の収集、レビュー、整理、提出支援

• 重要書類パッケージ（Critical Document Package; CDP）や施設立ち上げに必要な書類の収集・整理をサポートし、スポンサー及び治験責任医師の義務がICH/GCP及び規制要件に準拠していることを確認

• CDPチェックリストに基づく書類の正確性・完全性の確認および進捗管理ツールの更新

• 立ち上げに必要な書類の翻訳調整をサポート

• 治験施設から収集した書類や施設立ち上げに関わるデータを、適切な管理システムに正確かつタイムリーに入力・管理

• 施設立ち上げ計画の正確な予測とシステムへの反映、計画達成に向けたフォローアップ

• 内部試験レビュー会議に参加し、施設立ち上げに関わるリスクの特定・評価・対応策の検討に貢献

• スタートアップ時に提出される治験マスターファイル（TMF）書類の正確性・完全性を確保し、保管前の品質管理（QC）レビューを実施

■ 応募資格

• 大学卒以上

• 臨床開発業界での実務経験3～6年

• 優れた組織力、タスクの優先順位付け能力、複数業務の調整能力

• PCスキルおよびMicrosoft Officeの基本操作スキル

• 自律的に業務を遂行し、期限内に効率よく完了できる能力

• 必要に応じて他のサイトスペシャリストのサポートが可能なこと

• 社内関係者との良好なコミュニケーション能力

• 試験および施設のリスクを把握し、管理ツールに適切に記録・報告できる能力

• 他の試験チームメンバーと連携し、リスク対応計画の支援ができること

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