Senior Manager, FSA

Manager FSA - Tokyo Osaka -Office Hybrid

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.

We are currently seeking a Manager, FSA (Feasibility and Site Activation) to join our diverse and dynamic team. As a Manager, FSA (Feasibility and Site Activation) at ICON, you will lead teams responsible for delivering high-quality feasibility assessments and efficient site activation for global clinical trials. You will work closely with cross-functional partners to optimise start-up timelines, quality, and predictability for our customers.

What You Will Be Doing:

• 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.
• 担当地域、顧客、職能、または施設において、加速されたサイト立ち上げのタイムラインと最高水準の品質を確保するため、人員およびプロセスを効果的に管理する責任を持つ。すべての期限と目標が達成されるようにするとともに、割り当てられた人員、プロジェクト、職能、またはクライアントに関して、品質、顧客およびサイトの満足度、コストが最適に管理されるようにする

• FSA プロジェクトチームを管理し、国およびサイトの実行可能性調査、スタートアップ戦略、アクティベーション活動を、タイムラインと品質基準に沿って遂行する。

  担当する治験において、必須文書、規制当局・倫理審査委員会への申請、契約・スタートアップ関連パッケージの調整を統括する。

  実行可能性データ、前提条件、リスクを確認し、ステークホルダーと連携して、リスク軽減策および現実的なスタートアップ予測を策定する。

  提案書作成、ビッドディフェンス、顧客ミーティングにおいて、FSA の専門的なインプットを提供し、BD（ビジネスデベロップメント）およびオペレーションチームと協働する。

  実行可能性およびサイトアクティベーションに関するパフォーマンス指標をモニタリングし、トレンドを特定し、継続的な改善活動を推進する。

  FSA スタッフに対してコーチング、フィードバック、成長機会を提供し、責任感と協働を重視する文化を醸成する。

Your Profile:

• 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.

• 生命科学、ヘルスケア、ビジネス、または関連分野の学士号、もしくは同等の実務経験を有すること。

  実行可能性評価、サイト選定、スタートアップに強みを持つ、臨床研究における豊富な経験。

  スピード感のあるマトリクス型環境において、プロジェクトまたはチームを管理した実績。

  実行可能性データやオペレーション指標を解釈した経験を含む、優れた分析力および計画策定能力。

  顧客対応経験を含む、卓越したコミュニケーション能力およびステークホルダーマネジメントスキル。

  品質、予測可能性、オペレーショナルエクセレンスに注力した、継続的改善のマインドセット。

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