SSU Manager

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 an SSU Manager open to an office based role (+/- 3 days per week) in Paris.

The role involves being dedicated to EU-CTR submissions and document preparation.

We are seeking a candidate with experience in Oncology, EU-CTR, and IVDR and with at least 2 years of experience in a similar position (CRO or pharma).

• The SSU Manager is responsible at country level for managing and conducting start-up activities in compliance with procedures, documents, local and international guidelines.
• The SSU Manager will prepare, review, track and manage site regulatory documentation at country and site level, and will maintain, review and report on site performance metrics.
• The SSU Manager works in close collaboration with the CRAs and the Local Study Team to ensure that the start-up activities and milestones are achieved in a timely and efficient manner.

You will need

• Experience in EU-CTR, and IVDR
• Experience in Oncology
• At least 2 years of experience in a similar position (CRO or pharma)
• Good knowledge of international guidelines as well as relevant local regulations
• Good interpersonal skills
• Excellent attention to details

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

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Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

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, 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 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