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.
弊社の臨床開発部門において、臨床試験におけるCTM業務(主にグローバル試験)をお任せいたします。※CRA、他内勤ポジション等ラインマネジメント業務は、弊社のClinical Operations Managerが別途行います。
※弊社のフルサービス部門もしくはFSP部門いずれかへの配属を想定しています。
[具体的には]
臨床試験の運営管理全般
・モニタリング業務における日本国内メンバーのリーダー役を担う(モニタリングの監督責任)
・施設の立ち上げに関しては、Feasibility&Site Activation teamと連携して進める
・Global team memberとして、試験関連手順書およびマニュアルなどの作成(Project Managerと連携)
・Localで試験に要する費用マネジメント
・Local で各種ベンダーが行う業務のマネジメント
・文書管理コンプライアンス、各施設におけるクオリティ担保
※クリニカルモニタリングにおける、Primary LiaisonおよびPrimary Point of Escalationとして、クライアント、パートナー(ベンダー)、モニタリングチームのみならず、モニタリングチーム以外の部門とも必要に応じて連携しながら、プロジェクト推進を行っていただきます。
【職務経験等:
必須要件】
製薬メーカーまたはCROにおけるCTM経験(目安2年以上)
業務遂行に必要な英語スキル
We are currently seeking a Clinical Trial Manager to join our diverse and dynamic team at ICON Plc.
In this critical role, you will be responsible for overseeing the planning, execution, and successful completion of clinical trials, ensuring adherence to timelines, budgets, and regulatory guidelines.
As a leader in our research department, you will collaborate with cross-functional teams, manage site relationships, and provide strategic guidance to drive the successful delivery of clinical trial outcomes.
What You Will Be DoingPlan and manage all aspects of clinical trials, ensuring adherence to timelines, budget, and quality standards.
Collaborate with cross-functional teams to establish and implement clinical trial protocols and procedures.
Build and manage strong relationships with trial investigators and stakeholders.
Ensure all trials are conducted in compliance with local, national, and international regulations and ethical guidelines.
Problem-solve and make critical decisions regarding trial design, vendor selection, and risk management.
Your Profile
University degree in medicine, science, or equivalent combination of education & experience
Demonstrated ability to drive the clinical deliverables of a study
Subject matter expertise in the designated therapeutic area
Prior monitoring experience is preferred
Ability to travel up to 20%
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 IncludeVarious 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 assuranceFlexible 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.
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