Study Start Up Associate / Contract Negotiation - Italy - Italian Speaker

Study Start Up Associate / Contract Negotiation - Italy -  Italian Speaker

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.

Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That’s our vision. We’re driven by it. And we need talented people who share it.
If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.

The Role:
As a member of the Study Start Up Team, you will play an integral role in making sure that physicians at our research sites are prepared to start the trial of investigational, new pharmaceutical and biological products for clinical trials at their local practices.

• 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.
• Prepare, review and approve  Subject Information Sheets (SIS) and Informed Consent Forms (ICF),
• Prepare, review and negotiate Clinical Trial Agreements, budgets and any required ancillary agreements with assigned Study Sites,
• Collect, review, organize and assemble regulatory initial start-up and maintenance submission packages to Central EC/IRB, Local EC/IRB, Competent Authorities, any other local regulatory authorities as required by countries, Essential Country and Site document collection and review, ensuring that Sponsor and Investigator obligations are being met and are in compliance with applicable country requirements ICON SOPs/WPs, Sponsor SOPs, applicable country regulations/guidelines and the principles of ICH/GCP.
• Embrace and contribute to ICON’s culture of delivery, quality and process improvement with a focus on internal stakeholders’ collaboration, enhancing processes, systems and tools, adding value to our business, shortening Site Activation timelines and meeting client's expectations. This will translate in predicting and delivering site activation within predicted timelines, and ahead of industry standards

What you need
• A high school diploma or local equivalent
• Bachelor’s Degree preferably in Life Sciences
• Minimum of 1 years’ experience or understanding of clinical study start up requirements and activities.
• Experience of Clinical Trial operations and meeting regulatory guidelines
• Proficient project management skills.

Benefits of Working in ICON:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON 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 through the form below.

 #LI-remote #LI-AC1