SMA II

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.

You will be dedicated to one of our global Biotech client; with whom ICON shares a culture of innovation, flexibility and a common vision of bringing life-improving drugs to market. Leading by example, you can set the standard of excellence and enjoy a challenging career in our exclusive programs

Key responsibilities include: 

• Link between CRA and rCTMA in ISF binder preparation and adaptation and assuring availability at the site before SIV. ISF binder preparation
• Lab ranges, supporting CRA in range collection and uploading
• CTMS updates (site accounts, site contacts, milestones, site ICFs), supporting CRA and SSUs
• TMF (document filing, reconciliation and review at site level or country level (for SSU documentation), ISF review and reconciliation eTMF in close-out at site level.
• ICF- customization per site, eTMF upload country and site ICF
• Help with revision of documents to be submitted (SSU)
• Lab kits (follow arrival).
• Ad hoc printing and shipping documents to sites
• Organizing meeting and taking minutes, when required
• Support to dashboard review for quality purposes
• Support to track specific country logs
• Support with resolving data queries/site issue
• Support with payments follow up (sites, stakeholders)
• Tracking of receipt of SUSARs
• Assistance to completion of Debarment forms

You will need:

• A strong experience as a CTA or SMA, this within the pharmaceutical, Biotech or CRO company
• Experience in QC-TMF, CTMS, eTMF management
• Strong IT skills
• Strong communication with the ability to multitask and work effectively under pressure
• Flexible and proactive mindset
• Fluency in French and professional proficiency in English

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

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. 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, 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.

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.