SSUA
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 DoingLeading 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.
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.
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.
Show more Show less
-
Tokyo ICON Strategic SolutionsWe are 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 contributing to advancement of inN ...
-
Japan BeiGeneBeOne is a global oncology company discovering and developing innovative treatments for cancer patients worldwide. · ...
-
Tokyo, Tokyo Planet PharmaThis role sits within Clinical Operations Excellence and acts as a local subject matter expert for Study Start-Up (SSU) activities. · ...
-
Minato AbbVie+Job summary · We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. · +ResponsibilitiesSupporting the Study Project Manager ...
-
Tokyo ICON Strategic Solutions ￥4,000,000 - ￥6,400,000 per yearWe're proud to foster an inclusive environment driving innovation and excellence, · 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 clin ...
-
Tokyo Pfizer ￥4,000,000 - ￥8,000,000 per yearJapan Study Manager manages in-country study/site management and clinical/scientific oversight activities of assigned clinical trials to ensure patient safety and quality study execution. · Leads and coordinates the execution of a clinical trial from study start-up through databa ...
-
Tokyo Pfizer Full time￥4,000,000 - ￥8,000,000 per yearResponsible for in country study/site management and clinical/scientific oversight activities of assigned clinical trials to ensure patient safety and quality study execution in accordance with applicable prevailing laws Good Clinical Practices GCP and Pfizer standards. · ...
-
Chūō アステラス製薬 ￥50,000 - ￥100,000A Clinical Site Manager II (CSM II) serves as the primary contact point between the Sponsor and the Investigational Site.Responsibilities May Include Assisting With Or Primary Responsibility For · Site Selection · Pre-trial assessment · Site level Study Participant recruitment/re ...
-
Contract Specialist
1ヶ月前
Tokyo Medpace ￥2,000,000 - ￥2,800,000 per yearOur clinical operations activities are growing rapidly, and we are currently seeking new grads for full-time, office-based Contract Specialist to join our Clinical Operations team in Japan. · ...
-
Tokyo MedpaceWe are currently seeking a full-time Associate Director/Director to join our Site Contracts team in Tokyo. If you want an exciting career leading a team throughout the Study Start-Up Process, then this is the opportunity for you. We offer customized training program; annual compa ...
-
Tokyo Pfizer Full time￥4,500,000 - ￥9,000,000 per yearManage study sites in Japan, ensuring patient safety and quality execution of clinical trials. Collaborate with CROs and Pfizer standards. · ...
-
Tokyo Pfizer ￥600,000 - ￥1,800,000 per yearResponsible for in country study/site management and clinical/scientific oversight activities of assigned clinical trials to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and Pfizer standards. · ...
-
Tokyo MedpaceWe are seeking new grads for full-time Contract Specialist positions in Japan.This position plays a key role in the study start-up and clinical trial management processes at Medpace. · ...
-
Tokyo Abbott Full timeThis role is responsible for managing study documentation and operational progress using Clinical Trial Management System while maintaining highest quality standards in clinical study execution. · ...
-
Statistician/統計担当者
1ヶ月前
Tokyo Pfizer ￥7,000,000 - ￥8,000,000 per year· Provide scientifically rigorous statistical input into study design/plans/interpretation. · Develop effective collaborations within clinical teams/partner lines/external organizations. · ...
-
Tokyo MedpaceMedpace is a full-service clinical contract research organization (CRO) that provides Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical the ...
-
Tokyo MedpaceThis position plays a key role in the clinical trial management process at Medpace.Customized training program; · Hybrid work style and adaptable working hours; · Annual company bonus; · Annual merit salary increases; · Defined Contribution Plan; · Group term life insurance; · In ...
-
Tokyo MedpaceWe are seeking a Regulatory Submissions Coordinator to join our Site Activation & Maintenance team in Tokyo. This position plays a key role in the clinical trial management process at Medpace. · ...
-
Tokyo Ferring Pharmaceuticals Full time￥6,000,000 - ￥12,000,000 per year+The Head Reproductive Medicine will lead medical strategy planning across local/regional/global brand strategies to maximize product value. · Develop strategic medical plans · Accountable for cross-functional brand team · ...
-
Tokyo Ferring PharmaceuticalsThis role is responsible for developing and executing strategic medical plans for each product in alignment with local/regional/global brand strategies to maximize the product value. · ...
-
Tokyo Thermo Fisher Scientific Full timeJoin our team at Thermo Fisher Scientific as an Account Manager II. · ...
