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

What you will be doing:

• receiving all study documentation from the Project Team, Client, or Clinical Research Associate
• logging information into an internal tracking system
• scanning documentation to the correct location in an electronic repository
• setting up the Trial Master File (TMF) per the client-approved specifications and PRA standards
• maintaining files in regards to upkeep of the folders, application of study-specific labels, and assessment of supply needs for each aligned project
• running monthly reports to ensure accuracy of the files
• delivery of the Trial Master File at study closeout
• the review and preparation of the Trial Master File for audits and TMF reviews
• the resolution of any internal quality control findings and audit findings
• running of projections and maintenance of department reports
• creation of checklists and daily quality control schedules
• attending project calls with clinical team members applicable; and management of larger and/or more complex studies

You are:

• Undergraduate degree (e.g. Associate’s or Bachelor’s) in a clinical, science or related field
• Prior experience in records management, office support or similar duties
• Prior experience using computerized information systems
• Prior industry experience
• Prior experience in a leadership role
• Prior accountability with vendors or clients
• Read, write, and speak fluent English; fluent in host country language
• Knowledge of ICH/GCP, local regulatory authority and clinical development regulations

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, inclusion & belonging are fundamental to our culture and values. 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, 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 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.