Ref #: 33715

Employment type: Permanent - Full-Time

Location: Lombardy

Posted: 12-Nov-2021


The role:

* in cooperation with the Local Study Team, contributes to sites identification, feasibility and selection
* 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

To be successful in the role, you will have:

* 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 1/2 years

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and 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.