Site Specialist I/II (Study Start Up Associate I/II)
- Hong Kong
- Study Start Up
- ICON Full Service & Corporate Support
- Office Based
TA Business Partner
- Full Service Division
About the role
Study Start Up Associate I/II - Hong Kong- Office Hybrid
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.
Recognize, exemplify and adhere to ICON’s values of Accountability and Delivery, Collaboration, Partnership and Integrity, which center around our commitment to Ownership.
Proficient knowledge of ICON SOPs/WPs, ICH/GCP and applicable country regulations/guidelines and ICON systems.
Work with Site Partners and internal key stakeholders to optimize study performance and collaborate to ensure successful site activation and project outcomes.
Support Site Partners on complex or on program of studies to proficiently collect, review, organize and assemble regulatory initial start-up and maintenance submission packages to Central EC/IRB, Local EC/IRB, Competent Authorities, any other local regulatory authorities as required by countries and in accordance with ICH/GCP and applicable country regulations/guidelines.
Support collection and assembling of all documents needed in the Critical Document Package (CDP) and of those required for site activation, ensuring that Sponsor and Investigator obligations are being met and are in compliance with applicable requirements and ICH/GCP guidelines.
Ensure accuracy and completeness of the Critical Document Package according to CDP checklists and timely update of the required tracking tools.
Support coordination of all necessary translations required for any start-up documentation.
Proficient in timely and accurate progress data entry of all documents collected from sites and relevant study site activation activities into the appropriate tracking systems and tools and oversee that the site activation tasks are executed according to site activation requirements.
Accurately forecast Site Activation plans and ensure they are reflected accurately in ICON’s systems, proactively follow through for achievement to plan.
Contribute to effective site activation process and timelines: participate to internal study review meetings with study teams to contribute and support risk identification to site activation, mitigation and action planning.
Ensure accuracy and timely completeness of Trial Master File (TMF) documents submitted during start-up and perform a Quality Control (QC) review of files before transfer to maintenance for filing in TMF.
Other duties as assigned
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. See all locations Learn more about Our Culture at ICON
Day in the life
.jpg)
Teaser label
Inside ICONContent type
BlogsPublish date
01/17/2025
Summary
Five Reasons Why You Should Work at a Contract Research Organization Contract research organisations (CROs) play a pivotal role in advancing medical science, offering career opportunities that are
.jpg)
Teaser label
Career ProgressionContent type
BlogsPublish date
05/10/2024
Summary
Although many employers are returning to the office, we’re still seeing a mix of both video and in-person interviews in application processes. Early in 2020, the number of companies using video interv
.png)
Teaser label
Career ProgressionContent type
BlogsPublish date
12/21/2022
Summary
Salary expectations used to be something discussed after an interview process but now it’s something most recruiters typically ask within the first conversation. This is to ascertain if the remune
Similar jobs at ICON
Salary
Location
Brazil
Department
Study Start Up
Location
Brazil
Remote Working
Home-Based
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
2025-121635
Expiry date
01/01/0001
Author
Magda ObregonAuthor
Magda ObregonSalary
Location
Seoul
Department
Study Start Up
Location
Seoul
Remote Working
Office Based
Business Area
ICON Strategic Solutions
Job Categories
Study Start Up
Job Type
Permanent
Description
Study Start Up Associate- South Korea You will play a vital client facing line management role, embedded in our clients business. You will be responsible for the management of day to day clinial trial
Reference
2025-121314
Expiry date
01/01/0001
Author
Sonia OhAuthor
Sonia OhSalary
Location
Greece
Department
Study Start Up
Location
Greece
Remote Working
Home-Based
Business Area
ICON Strategic Solutions
Job Categories
Study Start Up
Job Type
Permanent
Description
As a Study Start Up Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. Providing innovative solutions for our cl
Reference
2025-121947
Expiry date
01/01/0001
Author
Alexander SourounisAuthor
Alexander SourounisSalary
Location
Bulgaria, Sofia
Location
Sofia
Prague
Warsaw
Lisbon
Barcelona
Remote Working
Office or Home
Business Area
ICON Full Service & Corporate Support
Job Categories
Site Activation
Job Type
Permanent
Description
We are currently seeking a Site Activation Lead to join our diverse and dynamic team. As a Site Activation Lead at ICON, you will advance clinical trial start-up activities by understanding client obj
Reference
JR133229
Expiry date
01/01/0001
Author
Magda KozuszekAuthor
Magda KozuszekSalary
Location
Bulgaria, Sofia
Location
Sofia
Remote Working
Office or Home
Business Area
ICON Full Service & Corporate Support
Job Categories
Study Start Up
Job Type
Permanent
Description
We are currently seeking a Senior Site Specialist to join our diverse and dynamic team. As a Senior Site Specialist at ICON, you will be working within a large-scale, fast-paced environment, supportin
Reference
JR129610
Expiry date
01/01/0001
Author
Magda KozuszekAuthor
Magda KozuszekSalary
Location
Mexico, Mexico City
Location
Mexico City
Remote Working
Office or Home
Business Area
ICON Full Service & Corporate Support
Job Categories
Study Start Up
Job Type
Permanent
Description
We're currently seeking a Senior 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
Reference
JR133508
Expiry date
01/01/0001
Author
Florencia Borello TaianaAuthor
Florencia Borello Taiana