Docs Global (Continental Europe)

Study Start Up Specialist (SSU) - Lombardy

01 May 2021
31 May 2021
Full Time
Contract Type
Experience Level
Experienced (non-manager)
Key responsibilities:

* 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


* 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


Why join the DOCS team at ICON?

Working at ICON is more than a job, it's a calling for people who care and are passionate about improving patients' lives. At ICON, we care about our people and your passion, you are key to our success. We aim to provide an open and friendly work environment where we empower our people and provide them with opportunities to develop their long-term career.
It takes courage to move from one job to another, the process involves careful consideration. Reach out having the conversation that would change your life and the lives of our patients. Our team of recruitment experts will provide the information you need in making the right decision.
At ICON you will have the opportunity to work with one of the global top 20 pharmaceutical companies, working on novel therapies that deliver real impact. If you want a career with a difference, ICON is the place for you.

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