Project Manager, FSA

Project Manager, FSA - Tokyo Osaka - Office Hybrid Home

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

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

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

Visit our careers site to read more about the benefits ICON offers.

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.

Are you a current ICON Employee? Please click here to apply