Senior Study Start Up

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, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

We are looking for a motivated Study Start Up Associate/Sr. Study Start Up Associate in Milan Area to join our sponsor dedicated team!

Key responsibilities:

•  in cooperation with the Local Study Team, contributes to sites identification, feasibility and selection
•  Collect, prepare, review, approve, process and track regulatory and site level critical documents required for study site activation in accordance with ICON SOPs/WPs, Sponsor SOPs, applicable country regulations/guidelines and the principles of ICH/GCP.
• in cooperation with the Local Study Manager, contributes to define the local submission strategy to RA and ECs
   is the main point of contact for the global RPM/RPA and Local Study Team for new CTA / SA / Notification / General communication with local RA and ECs
• review all the documents dispatched by the global RPM/RPA for local RA submission
•  prepare all applicable documentation for submission to local RA and ECs (i.e. local language Cover Letter, local language label for locally supplied drug, local ICFs and other patients document, Insurance certificate)
• negotiate Financial Agreement (legal text and budget) with Institutions
•  perform QC on documents submitted and received by RA/ECs
•  maintains data tracking for RA and EC study oversight
•  keeps Local study Team informed on approvals timelines and regarding any potential/actual issue related to site activation. Contributes to issue resolution.
•  maintains tracking of documentation submitted to/approved by RA and ECs
•  contribute to the improvement of the study start up processes and other related procedures

You are: 

* University degree in biological science or healthcare-related field, or equivalent
* Good knowledge of spoken and written English
* Good ability to learn and to adapt to work with IT systems
* Good knowledge of GCP
* Good time management and organisation skills, ability to prioritize and multitask;
* Good oral and written communication skills
* Goal oriented attitude
* Diplomatic and interpersonal skills
* Good ability to have attention to details
* Ability to work independently as well as in team working
* Previous experience in the role years and with CTIS

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, 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, colour, 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.