At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.
As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.
As a Clinical Trial Manager (role: Study Start Up Manager) at ICON, you will be responsible for study planning, SSU activities and activation deliverables of assigned projects in compliance with ICON processes, GCP/ICH and regulatory requirements in a standalone country, OPC (operating country) or satellite country. Leads all SSU activities of assigned projects in close collaboration with Feasibility Manager and Site Partnership Manager as well as the global study team. In satellite countries acts as primary back-up and deputy of the country manager.
You will have solid clinical trial management experience, with the ability to manage competing priorities and develop your team.
- SSU strategy in close collaboration with Study Start-Up Team
- SSU timelines and deliverables are met according to country
commitments
- Timely start-up activities from country allocation until Green Light
(ready to initiate site millstone) in assigned projects
- Close collaboration with local IRBs/IECs and Health Authorities, as
applicable
- Study start-up activities are conducted and completed on time,
including preparation of IRB/IEC submission packages, review of
Informed Consent Forms, engaging Regulatory Affairs/CTA Hub for
Health Authorities submissions, as required
- Prepares and finalizes local submission package for submission to
IRB/IEC, CTA Hub as well as Health Authorities
- Leads site selection in collaboration with local and global
stakeholders
- Experience managing outsourced studies to CROs
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.
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
Apply on ICON PLC’s careers page