Project Manager, FSA

Project 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 Project Manager, Feasibility and Site Activation (FSA) at ICON, you will be responsible for planning and manage Feasibility and Site Activation (FSA) activities for assigned clinical studies.

What You Will Do:

You will oversee site start-up and activation workstreams, ensuring deliverables meet quality and timeline expectations.

Key responsibilities include:

• Developing and managing FSA project plans, timelines, and deliverables for assigned studies.
• Coordinating feasibility assessments, country and site recommendations, and start-up strategies in collaboration with functional experts.
• Overseeing essential document collection, ethics and regulatory submissions, and site activation milestones.
• Tracking progress against timelines and KPIs, proactively identifying risks and implementing mitigation plans.
• Serving as the primary FSA contact for internal teams and customers for study-level start-up matters.
• Contributing to process improvement and best practice sharing within the FSA project management team.

Project Manager, FSAとして下記業務をご担当いただきます。

・施設の選定を実施後、Site Specialist/Site Contract Negotiator が実施する各施設の立ち上げマイルストンをオーバーサイトいただきます。

・プロジェクトレベルでの立ち上げに特化したポジションであり、立ち上げ期のあらゆる側面（予算、リソース、Site Activation planの作成・管理など）を管理・リードすることでスケジュール内での Site Activation を成功に導いていただきます。

（ラインマネジメントではなく Site Activationの業務に関してリードを行うポジションです）

・社内チームや関係者だけでなく、必要に応じてスポンサー側のチームや関係者とも連携を図り、課題解決や顧客の期待値に即した対応をいただきます。

・監査や査察において、FSA（施設立ち上げ担当者）として対応いただきます。

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.
• Strong experience in clinical research with a focus on feasibility, site activation, or start-up project management.
• Proven ability to manage project plans, timelines, and cross-functional coordination in a fast-paced environment.
• Good understanding of regulatory, ethics, and contractual requirements affecting study start-up.
• Excellent communication, organisational, and stakeholder management skills.
• Detail-oriented and proactive, with a commitment to quality, predictability, and customer satisfaction.
• Willingness to travel as required (approximately 10%)

応募要件

■下記いずれかのご経験をお持ちの方

・臨床試験の立ち上げにおけるリードもしくはリードのサポートの経験例：立ち上げにおける予算、リソースの管理、Site Activation Planの作成・管理などいずれかのご経験をお持ちの方

・PMやCTMとしての経験

■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