Project Manager, FSA

Project Manger, FSA

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

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

・PM、CTM とともに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。

・担当いただく試験については日本国内のみならず、ご経験やスキルに応じてAPAC を中心とした他国での試験へのアサインも想定しており、欧米での試験へのアサインの可能性もございます。

• Recognize, exemplify and adhere to ICON's values , and contribute to the “Own It” culture at ICON
• Accountable for driving and accelerating the activation or maintenance activities of global investigative sites in line with, or ahead of, the study's contractual timelines, within budgeted resources, with quality output, and exceeding sponsor expectations. Accountable for the overall coordination, implementation and completion of site activation activities for assigned projects of work in line with ICON/sponsor SOPs as appropriate, including regulatory/ethics, site contracts, essential documents, and site activations. Interacts with internal teams and stakeholders, as well as sponsor teams and stakeholders as needed.
• Lead studies with highest quality standards to exceed customer expectations.
• Review study and partnership budgets for proposals and sales as needed.
• Drive assigned studies to meet KPIs and delight customers and sites
• Act as customer point of contact for assigned studies; resolve study issues and drive exceptional customer delivery
• Represent FSA at audits and inspections
• Participate in Business Development opportunities to support the growth of the assigned portfolio, function, and/or region/country(ies)
• Travel (approximately 10% depending on country structure and direct report levels) domestic and/or international
• Responsible for performing activities that are in compliance with applicable corporate and departmental policies, standard operating procedures and operating guidelines and performing other duties as assigned by the management

What ICON can offer you:

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.

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