Clinical Trial Assistant (CTA)

As a Clinical Trial Assistant you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

The Clinical Trial Associate (CTA) supports Study Start-Up Manager and Clinical Project Manager in assigned studies during set-up and whole study lifecycle in compliance with Novartis processes, GCP/ICH and regulatory requirements.

Your responsibilities:

• Supports document collection, preparation, and adaption for submission to IRB/EC and Health Authorities as applicable
• IF and TMF management (country and site TMF); set-up and maintenance according to regulatory and sponsor requirements; document oversight and tracking
• Supports Vendor set-up as applicable
• Checks site completeness and ensures all documentation is in place for initial and subsequent drug release in collaboration with the local Qualified Person(s)
• Supports preparation and translation of ICF into local languages (including vendor management if necessary)
• Supports preparation of patient facing material
• Responsible for completeness of uploaded trial related documents 
• Supports country SSU strategy in close collaboration with SSU Team Lead and SSU Managers to ensure SSU timelines and deliverables are met according to country commitments
• Ensures adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirements
• Provides logistic support to SSU CRA, CRA, CPM, SSU Manager in all phases of the clinical trial
• Implements innovative and efficient processes which are in line with sponsor strategy 

You are:

• Preferably Master/Bachelor degree in life sciences
• Very good English – written and spoken
• 1 year previous experience of working in clinical research
• Ability to work independently in a structured and pro-active manner as well as part of the different trial teams
• Very good communication skills - ability to communicate and build relationships with various stakeholders
• IT proficiency (including MS Office: Outlook, Excel, Word, PowerPoint)
• Knowledge of eTMF systems, such as Veeva Vault is considered an advantage

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

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.

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