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FSA-Site Contracts Negotiator Ⅰ, Site Contracts Negotiator II and Senior Site Contracts Negotiator

  1. Osaka, Tokyo
JR132253
  1. ICON Full Service & Corporate Support
  2. Contracts Administration
  3. Office Based

About the role

FSA-Site Contracts Negotiator Ⅰ, Site Contracts Negotiator II and Senior Site Contracts Negotiator

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:

Responsible for the successful negotiation and on-going maintenance of clinical trial agreements, complex amendments, and other ancillary agreements with study sites.

Responsibilities:

  • Drafts, reviews, negotiates, and finalizes clinical trial agreements, complex amendments, and other ancillary agreements with study sites using critical thinking, available tools/systems/documents, historical data, and adheres to departmental and/or client quality check requirements in a manner that protects ICON’s fundamental interests and is consistent with ICON’s rules, procedures, and policies.
  • Maintains consistent communication with study sites and internal stakeholders in alignment with site contracts department and client requirements.
  • Tracks progress of site contracts agreements and related documents regularly in required ICON and client systems.
  • Proactively identifies and raises risks, while also, suggesting mitigation plans to established study milestones and planned site contracts timelines.
  • Files contractual documents as per department, ICON, and client requirements.
  • Attends and participates in study team project calls, as applicable.
  • Works cross functionally with internal stakeholders in support of timely site start up and maintenance for the conduct of clinical trials including accurate forecast of contract execution timelines.
  • Reviews site contracts for completeness and accuracy and ensures adherence to department and client requirements, corrects documents, and files changes to contracts.
  • Completes all required project, client, department, and ICON trainings on time and adheres to the applicable SOPs, processes and procedures.

What you need:

  • Bachelor’s Degree
  • 0-3 years of experience in a Clinical Research environment
  • Demonstrates professionalism in conducting daily activities.
  • Exhibits extensive competency in Microsoft Office Suite applications (i.e. Word, Excel, PowerPoint, Outlook).
  • Ability to follow written and oral instructions from a variety of sources.
  • Completes tasks independently on time and in an efficient manner.
  • Ability to mentor and train other site contracts team members as needed.
  • Demonstrates effective time management skills and has ability to prioritize multiple tasks with management guidance and oversight.
  • Strong attention to detail.
  • Great interpersonal and communication skills.
  • Confidence in dealing with external and internal clients.

ロール概要

臨床試験に関する契約書や複雑な修正契約、その他付随契約について、治験実施施設との交渉および維持管理を成功裏に進める役割です。

主な業務内容

  • 治験実施施設との臨床試験契約、複雑な修正契約、その他付随契約について、社内ルールやポリシーを遵守しながら、クリティカルシンキングとツール・データを活用して起案・レビュー・交渉・締結

  • 施設および社内関係者と継続的に連絡を取り、部署およびクライアント要件に沿った調整を実施

  • 契約および関連文書の進捗状況をICONやクライアントのシステム上で定期的に管理

  • リスクを積極的に特定・報告し、スタディのマイルストーンや予定契約スケジュールに対してリスク軽減策を提案

  • 契約関連文書のファイリングを部署・ICON・クライアントの要件に沿って適切に管理

  • 必要に応じてスタディチームのプロジェクト会議に参加

  • 治験のスムーズなサイト立ち上げ・維持のために社内関係者と連携し、契約締結までのスケジュールを正確に予測・支援

  • 契約書の正確性・完全性を確認し、必要に応じて修正や変更内容の反映を実施

  • プロジェクト・クライアント・部署・ICONの各種トレーニングを期限内に受講し、関連するSOP・プロセスを遵守

応募要件

  • 学士号以上

  • 臨床開発領域で0~3年の経験

  • 日常業務における高いプロフェッショナリズム

  • Microsoft Office(Word, Excel, PowerPoint, Outlook)の高い操作スキル

  • さまざまな指示を的確に理解し対応できる能力

  • 自立的かつ効率的に業務を遂行できる方

  • 必要に応じて他の契約チームメンバーへの指導ができる方

  • 複数の業務を優先順位をつけて管理できるタイムマネジメント力

  • 細部に注意を払う力

  • 優れた対人・コミュニケーションスキル

  • 社内外のクライアントに対して自信を持って対応できる方

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

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