Part Time CTA - 0.8 FTE, Copenhagen

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

What you will be doing:

• • • Liaise with clinical team to help compile initial and amended regulatory / administrative document package for the central and local IRB/IECs and sites (including site Administrations).
    • Track the status of regulatory readiness and alert the Clinical Study Manager appropriately to any issues/challenges in getting sites ready.
    • If relevant, work with translating agencies to support translation of relevant clinical study documents.
    • Check that appropriate versions of legal documents (e.g. Confidentiality Agreements, CTA) are used and database is kept current. Liaise with legal to track and process agreements.
    • Responsible for efficient upload of trial related documents/communications in to CREDI.
    • In collaboration with CSMs and CRAs, responsible to set-up and keep country and site Trial Master Files (“TMFs”) continuously up to date according to regulatory and Sponsor requirements.
    • Assists local trial team with the creation, ordering, and mailing of any study tools including recruitment materials as well as newsletters, blast email communications, blast faxes, etc.
    • Supports local trial team with ordering/tracking/mailing of any necessary trials supplies including the regulatory binder, lab kits.
    • Support the CSM with the coordination of internal and external suppliers, including customs, to confirm import of all clinical trial supplies (including drug supply).
    • Coordinate shipment of clinical trial supplies to local sites.
    • Co-ordinate relabeling of Investigational Medicinal Product (“IMP”) at warehouse when needed.
    • Supports the Trial Commitment Form (“TCF”) specialist. Provide support for trial budget and accounting.
    • Support budget planning and forecast. Support tracking and processing of Grant applications.
    • Track, process and release milestone payments to sites in collaboration with local study team and finance.
    • Track, process and release payments to vendors in collaboration with local study team and finance

You will need:

• Various educational background.
• Preferably, three years’ work experience with at least one year experience in clinical research.
• Basic knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
• Strong organizational skills.
• Strong ability to manage time and work independently.
• Excellent communication, presentation, interpersonal skills both written and spoken, with an ability to inform, influence, convince, and persuade.

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

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, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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.