Senior Regional CTA

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

Responsibilities:

• Supports the Regional Clinical Study Manager in regional study delivery and ensures that delegated components of clinical studies are executed to expected and specified quality standards, within timelines and budget
• Supports regional vendor management in addition to other regional study management activities
• Supports the Regional Clinical Study Manager with set up and logistics of regional team meetings (agenda, minutes)
• As required, supports CRAs with various activities such as monitoring visit preparations, TMF filing, etc
• Creates and maintains regional/country level SharePoint folders for the study and regional study team distribution lists
• Sets up the countries and sites in the region in the appropriate systems e.g. eTMF, CTMS, and makes sure information is kept up to date
• Supports system access requests for the region/country and ensure these are managed appropriately across the study life cycle, supports user account management for users in region
• Might support the local adaptation of global documents under supervision of the Regional Clinical Study Manager
• Supports study start up in region/country in close collaboration with the regional study start up team and the Regional Clinical Study Manager
• Supports the TMF specialist with country/site level TMF creation and maintains the country/site level TMF including regular review and QC of TMF documents as per the study TMF QC plan
• Might support the preparation of sites for quality assurance audits and inspections
• Suggests improvements to enhance the efficiency and the quality of the work performed on assigned projects
• Supports the development of local/regional tools, working instructions and SOPs
• Supports selection and set up of vendors for activities outsourced in region/country
• Supports management of regional study budget incl PO set up
• Supports management of regional vendors incl PO set up

Requirements:

• Bachelor’s Degree in a scientific or healthcare discipline required
• 2 or more years of experience in clinical research within biotech, pharma or CRO industry
• Knowledge of clinical operations methodologies, understanding of operational aspects of clinical study processes
• Experience in MS Office
• Fluent in English and the local language

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.

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