Manager, FSA at ICON plc

Osaka, , Japan -

Full Time

Start Date

Immediate

Expiry Date

06 Oct, 26

Salary

0.0

Posted On

09 Jul, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Site Start-Up, Site Activation, Feasibility Assessment, Line Management, Clinical Research, Stakeholder Management, Project Management, Resource Planning, KPI Monitoring, Regulatory Submissions, GCP Compliance, Analytical Skills, English Proficiency, Coaching, Risk Mitigation, Operational Excellence

Industry

Biotechnology Research

Description

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 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 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 ICON is an award-winning workplace that enables you to make a difference to patients’ lives by being part of a world-class clinical research organisation that helps deliver new medicines & medical devices that are benefitting patients worldwide. You are also part of a diverse company that cares about our world and is dedicated to conducting business more sustainably and supporting the communities in which we live. If you’re as driven as we are, join us. You’ll be working in a great environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry. Didn’t find the role you were looking for? Even if the perfect role isn’t available right now, we’re always excited to connect with talented individuals. Register to our Talent Community to receive updates on roles that align with your career goals.

Responsibilities

Lead teams in delivering high-quality feasibility assessments and efficient site activation for global clinical trials. Manage resource allocation, performance metrics, and regulatory submissions while fostering team development and operational efficiency.