Manager, FSA

Manager, FSA - Tokyo Osaka - Office Hybrid/Home

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.

As a Manager, Feasibility and Site Activation (FSA) at ICON, you will lead teams responsible for delivering high-quality feasibility assessments and efficient site activation for global clinical trials.

What You Will Do:

Your focus will be on coordinating site start-up and activation delivery, resolving issues, and developing team capability.

Key responsibilities include:

• Managing FSA project teams to deliver country and site feasibility, start-up strategies, and activation activities in line with timelines and quality expectations.
• Overseeing the coordination of essential documents, regulatory and ethics submissions, and contract/start-up packages for assigned studies.
• Reviewing feasibility data, assumptions, and risks, and partnering with stakeholders to develop mitigation plans and realistic start-up forecasts.
• Collaborating with business development and operational teams to support proposals, bid defences, and customer meetings with robust FSA input.
• Monitoring performance metrics for feasibility and site activation, identifying trends and driving continuous improvement initiatives.
• Providing coaching, feedback, and development opportunities to FSA staff, fostering a culture of accountability and collaboration.

• ・FSA部門のラインマネージャーとして、チームパフォーマンス、品質、納期およびリソース最適化に対する責任を担う

  ・担当チーム（目安：10-20名規模）のリソース配分、採用、育成、およびパフォーマンスマネジメントを実施

  ・各試験のSite Activation（Feasibility～Activation）がチームにより適切に計画・実行されるよう、体制構築、育成および必要な支援を通じて担保する

  ・Utilization、KPI、デリバリー指標をモニタリングし、継続的改善を実行

  ・Headcount planningおよびキャパシティ計画に基づき、業務需要に応じた最適な体制を構築し運営

  ・BDおよびProposal活動に参画し、立ち上げ戦略、リソース計画およびコスト観点から案件獲得を支援

  ・プロセス改善およびオペレーション効率化を推進し、siteおよび顧客満足度の向上を図る

  ・規制・GCP・社内SOPに準拠した業務遂行を担保し、監査・査察対応をリードまたはサポート

Your Profile:

You will have solid site start-up and activation experience, with the ability to manage competing priorities and develop your team.

Required qualifications and experience:

• Bachelor's degree in life sciences, healthcare, business, or a related field, or equivalent experience.
• Significant experience in clinical research with a strong focus on feasibility, site selection, and study start-up.
• Proven ability to manage projects or teams in a fast-paced, matrixed environment.
• Strong analytical and planning skills, with experience interpreting feasibility data and operational metrics.
• Excellent communication and stakeholder management skills, including customer-facing experience.
• Continuous improvement mindset, with a focus on quality, predictability, and operational excellence.
• Willingness to travel as required (approximately 15%)

• Clinical OperationsおよびStudy Start-Up領域における経験を有し、ラインマネジメント経験をお持ちの方、またはチームリードやプロジェクトマネジメントを通じた人材マネジメントのご経験のお持ちの方

  サイト立ち上げ（Feasibility～Activation）の実務経験

  複数タスクを管理できる能力をお持ちの方

  チーム育成およびパフォーマンス向上を推進した経験

  ビジネスレベルの英語力

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