Clinical Site Manager II

Astellas CSM

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 Senior Clinical Research Associate (CRA) to join our diverse and dynamic team. As a Senior CRA at ICON Plc, you will play a critical role in overseeing and managing clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards. You will contribute to the success of clinical trials by ensuring data integrity, participant safety, and compliance throughout the study lifecycle.

What You Will Be Doing:

• Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.
• Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution.
• Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting.
• Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct.
• Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations.

Your Profile:

• Advanced degree in a relevant field such as life sciences, nursing, or medicine.
• Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements.
• Proven ability to manage multiple sites and projects simultaneously, with strong organizational and problem-solving skills.
• Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools.
• Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment.

• Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver’s license

当社では、多様でダイナミックなチームの一員としてご活躍いただけるシニア・クリニカルリサーチアソシエイト（CRA）を募集しております。
ICON plc において、Senior CRAは臨床試験の実施状況を統括・管理し、試験がプロトコル、規制要件、および業界基準に従って適切に遂行されるよう重要な役割を担います。

本ポジションでは、データの信頼性確保、被験者の安全性の担保、ならびに試験ライフサイクル全体におけるコンプライアンス遵守を通じて、臨床試験の成功に貢献していただきます。

主な業務内容

• 臨床試験実施施設のモニタリングを行い、試験プロトコル、規制要件、およびGCP（Good Clinical Practice）への準拠状況を確認
• 施設訪問を実施し、パフォーマンスの評価、課題の解決、および試験の円滑な実施に向けた支援を提供
• クロスファンクショナルチームと連携し、データの適時かつ正確な収集・報告を推進
• 施設スタッフおよび他のCRAに対するトレーニングや指導を行い、臨床試験の品質維持に貢献
• 医療機関関係者やステークホルダーとの良好な関係を構築・維持し、試験運営を円滑に推進

応募資格

• ライフサイエンス、看護学、医学など関連分野における学位（修士号以上が望ましい）
• CRAとしての豊富な実務経験と、臨床試験プロセスおよび規制要件に関する深い理解
• 複数の施設およびプロジェクトを同時に管理できる高いマルチタスク能力、ならびに優れた問題解決能力
• モニタリング業務、データインテグリティ、施設管理に関する専門知識、および臨床試験関連システム・ツールの使用経験
• 優れたコミュニケーション能力・対人スキル・ステークホルダーマネジメント能力を有し、複雑な環境下でもコンプライアンスを推進できる方
• 国内外への出張が可能な方（目安：業務時間の60%以上）、および有効な運転免許証を保有している方

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