Business Operations Associate - Site and SSU Specialist
- Tokyo
- Study Start Up
- ICON Strategic Solutions
- Remote or Office
TA Business Partner
- Icon Strategic Solutions
About the role
Site and SSU Specialist - Tokyo - Client Office
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 Study Start Up Associate II to join our diverse and dynamic team. As a Study Start Up Associate II at ICON, you will play a pivotal role in leading the initiation of clinical trials, ensuring compliance with regulatory requirements, and contributing to the advancement of inNvative treatments and therapies.
What you will be doing
Leading the preparation and submission of regulatory documents, including clinical trial applications, ethics committee submissions, and regulatory agency communications.
Coordinating and liaising with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation.
Managing and maintaining comprehensive and accurate records of regulatory submissions, approvals, and correspondence
Providing guidance and support to study teams on regulatory requirements and best practices for study start-up activities.
Participating in process improvement initiatives to streamline study start-up processes and enhance efficiency
治験申請書、IRB提出資料、規制当局へのコミュニケーション文書など、規制関連文書の作成・提出を主導する
治験開始に必要な承認・許可を得るため、社内外ステークホルダーとの調整および連携を行う
規制当局への提出物、承認、関連文書の正確かつ包括的な記録を管理する
規制要件および治験開始のベストプラクティスについて、スタディチームへ指導・サポートを提供する
治験開始プロセスの効率化に向けた改善活動に参加し、業務の最適化を推進する
Your profile
Bachelor's degree in life sciences or a related field.
Minimum of 2 years of experience in clinical research or regulatory affairs, with specific experience in study start-up activities.
Strong understanding of regulatory requirements and guidelines for clinical trials, including ICH-GCP and local regulatory requirements.
Excellent organizational and project management skills, with the ability to prioritize and manage multiple tasks simultaneously.
Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
ライフサイエンス関連分野の学士号
治験または薬事関連業務で 2 年以上の経験があり、とくに治験開始(Study Start-Up)業務の経験を有する方
ICH-GCP および各国の規制要件など、治験に関する規制の深い理解
優れた組織力・プロジェクトマネジメント能力を持ち、複数タスクを同時に管理できること
クロスファンクショナルチームと効果的に協働できる、優れたコミュニケーション能力および対人スキル
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
Impactful work. Meaningful careers. Quality rewards.
At ICON, our employees are our greatest strength. That’s why we are committed to empowering you to live your best life, both inside and outside of work. Whether your ambition is lead a global team, become a deep scientific or technical expert, work in-house with our customers or gain experience in a variety of different ICON functions, we will support you in realising your full potential. Learn more about Our Culture at ICON
Day in the life
Similar jobs at ICON
Salary
Location
Argentina, Buenos Aires
Location
Buenos Aires
Remote Working
Hybrid
Business Area
ICON Full Service & Corporate Support
Job Categories
Study Start Up
Job Type
Permanent
Description
We are currently seeking a Site Specialist I (Study Start Up Associate I) to join our diverse and dynamic team. As a Site Specialist I at ICON, you will support investigator sites with key administrat
Reference
JR146306
Expiry date
01/01/0001
Author
Florencia PistolesiAuthor
Florencia PistolesiSalary
Location
Brazil, Sao Paulo
Location
Sao Paulo
Mexico City
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Study Start Up
Job Type
Permanent
Description
We are currently seeking a Study Start Up Associate II (Site Activation Partner) to join our diverse and dynamic team. As a Study Start Up Associate II at ICON, you will play a pivotal role in leading
Reference
JR147946
Expiry date
01/01/0001
Author
Elizabeth DaviesAuthor
Elizabeth DaviesSalary
Location
Italy, Milan
Location
Milan
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Study Start Up
Job Type
Permanent
Description
We are currently seeking a Study Start Up Associate I to join our diverse and dynamic team. As a Study Start Up Associate I at ICON, you will play a pivotal role in facilitating the initiation of clin
Reference
JR148037
Expiry date
01/01/0001
Author
Mattia CarcangiuAuthor
Mattia CarcangiuSalary
Location
India, Bangalore
Location
Bangalore
Chennai
Trivandrum
Bengaluru
Remote Working
Hybrid
Business Area
ICON Full Service & Corporate Support
Job Categories
Study Start Up
Job Type
Permanent
Description
We're currently seeking an Informed Consent Form (ICF) Specialist to join our diverse and dynamic team. As an ICF Specialist at ICON, you'll be crucial in ensuring the accuracy, compliance, and timely
Reference
JR146421
Expiry date
01/01/0001
Author
Hemalatha JaganathanAuthor
Hemalatha JaganathanSalary
Location
India, Chennai
Location
Bangalore
Chennai
Bengaluru
Remote Working
Hybrid
Business Area
ICON Full Service & Corporate Support
Job Categories
Study Start Up
Job Type
Permanent
Description
We are currently seeking an Informed Consent Specialist I to join our diverse and dynamic team. As an Informed Consent Specialist I at ICON, you will support the development, review, and management of
Reference
JR144999
Expiry date
01/01/0001
Author
Hemalatha JaganathanAuthor
Hemalatha JaganathanSalary
Location
Poland, Warsaw
Location
Warsaw
Remote Working
Office Based
Business Area
ICON Strategic Solutions
Job Categories
Study Start Up
Job Type
Temporary Employee
Description
We are currently seeking a Study Support Assistant to join our diverse and dynamic team to work on site in Tychy and Chrzanow. As a Study Support Assistant at ICON, you will play a pivotal role in pro
Reference
JR147668
Expiry date
01/01/0001
Author
Michal CzyrekAuthor
Michal Czyrek