Study Start Up Associate I
- Greece
- Clinical Trial Support
- ICON Strategic Solutions
- Remote
TA Business Partner
- Icon Strategic Solutions
About the role
This vacancy has now expired. Please see similar roles below...
As a Study Start Up Specialist you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
The SSU Specialist is responsible for the start-up of clinical trial activities in their assigned country/countries to achieve greenlight for selected sites. Specialist also performs quality review of essential documents at start up and during the lifecycle of the study, ensuring adherence to ICH-GCP guidelines, local requirements and Bayer QSDs.
Major Tasks:
- Interact with site and study personnel to collect country specific documents such as IRB/IEC approvals, financial disclosure, CVs/medical licenses, etc. and review for accuracy, completeness and adherence to ICH/GCP and Bayer QSDs
- Perform quality review of country and site level essential documents following a risk-based approach, issue queries, and communicate outcome to identified users at key milestones and during the course of the study
- Prepare and submit regulatory and IRB/IEC documentation as required per country requirements and Bayer QSDs during the course of the study
- Preparation, tracking, and distribution of site start up documentation including Investigator Site File
- Obtain any required approvals for relevant site document (e.g. informed consent, financial disclosures) to ensure start up timelines are met
- Manage oversight, in collaboration with CLM, of country and site start up activities and eTMF quality using Vault Clinical reports and dashboards
- Monitor internal start up KPIs across studies and identify and communicate trends
- Support start up process improvement implementation
You are:
• Bachelor’s degree (or equivalent experience) and minimum of 1 years of experience in clinical development including start up/ regulatory process experience
• Understanding of ICH-GCP essential documentation and familiarity with country specific clinical trial regulations
• Demonstrated ability to quality review documents and identify discrepancies/inconsistencies preferred
• Strong written and verbal English communication skills
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 maximise savings and plan with confidence for the years ahead
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others
Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits
At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. 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 through the form below.
https://careers.iconplc.com/reasonable-accommodations
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.
A better career. A better world. A better you.
Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
Day in the life
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
Teaser label
Inside ICONContent type
BlogsPublish date
01/26/2023
Summary
The CRO market has seen an unmistakable uplift in demand for its services in recent years. The call for personalised medicine, pricing pressures, and increasing complexity in clinical trials are j
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
by
Jamie Kempski
Similar jobs at ICON
Salary
Location
US, Raleigh (PRA)
Department
Clinical Monitoring
Real World Solutions
Location
Brentwood
Raleigh
Wilmington
Blue Bell
Lenexa
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Trial Support
Job Type
Permanent
Description
We are currently seeking a Site Management Associate to join our diverse and dynamic team. The Site Management Associate is responsible for managing, implementing and monitoring clinical studies, with
Reference
JR123278
Expiry date
01/01/0001
Author
Jasmine GarciaAuthor
Jasmine GarciaSalary
Location
Italy
Department
Clinical Operations Roles
Location
Italy
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Support
Job Type
Permanent
Description
ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotech
Reference
2024-113638
Expiry date
01/01/0001
Author
Mattia CarcangiuAuthor
Mattia CarcangiuSalary
Location
United Kingdom
Department
Clinical Operations Roles
Location
UK
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Support
Job Type
Permanent
Description
Role: Clinical Research AssociateLocation: UK, midlands (ideally) but open location wise, must be happy to travel across the UKFully sponsor dedicated ICON plc is a world-leading healthcare intellig
Reference
2024-113619
Expiry date
01/01/0001
Author
Amani YousefAuthor
Amani YousefSalary
Location
Cambridgeshire
Department
Clinical Operations Roles
Location
Cambridgeshire
Remote Working
Office Based
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Support
Job Type
Permanent
Description
CTA Cambridge (UK) 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 wel
Reference
2024-111843
Expiry date
01/01/0001
Author
Elisabeth TrivicAuthor
Elisabeth TrivicSalary
Location
France
Department
Clinical Operations Roles
Location
France
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Support
Job Type
Permanent
Description
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
Reference
2024-110913
Expiry date
01/01/0001
Author
Dominique CarilienAuthor
Dominique CarilienSalary
Location
France
Department
Clinical Operations Roles
Location
France
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Support
Job Type
Permanent
Description
The Sr. Study Site Specialist will be responsible for conducting end-to-end site management from feasibility to site activation serving as the primary point of contact for the site and the study team.
Reference
2024-113614
Expiry date
01/01/0001
Author
Katrien DoomsAuthor
Katrien Dooms