IHCRA - SSU

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.

As IHCRA -  Study Start Up , you’ll work with a collaborative and successful team to support our Clinical Trial Management and Project Management teams with operational activities. We pride ourselves on our amazing company culture, where we work as one team to achieve industry-leading results.

What you will be doing:

• • Prepare site specific ICF and any other relevant forms according to Sponsor local SOP.
  • Supports document collection, preparation and adaption for submission to IRB/EC and Health Authorities, as applicable
  • Prepare and compile dossier for initial HA and IRB submission or amendment and oversee associated activities, responses and communications with obtaining approvals for the assigned country(ies).
  • Translation of applicable study documents to local language
  • Provide support for trial budget and investigator site payments; support the project manager and team with financial tasks.
  • Check site “Green Light” completeness and ensures all documentation is in place for initial and subsequent drug release in collaboration with local Qualified Person
  • Supports preparation and translation of ICF to local languages(including vendor management, if necessary)
  • Supports preparation of patient facing material
  • Responsible for completeness of uploaded trial-related documents into CREDI/SUBWAY, including archiving of paper TMFs
  • Supports country SSU strategy in close collaboration with SSU Team Lead and SSU Mangers to ensure SSU timelines and deliverable are met according to country commitments
  • Ensure adherence to final standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirements
  • Maintains oversight of the entire purchase order process, from set-up to reconciliation, as well as the processing of study invoices.
  • May support, track and/or process grant applications
  • May mentor/on-board newly hired Clinical Trial Assistants and provide on-the-job training, as needed
  • May have some accountability for processes or groups of trials; operates with limited oversight
  • May ensure the successful negotiation and ongoing management of clinical disclosure agreements with investigative

You are:

• Min. Bachelor degree in Life Sciences
• Minimum 2 years of experience as Study Start Up
• Great planning and organizational skills
• Strong administrative skills
• Organizational skills to support several team members
• Excellent written and verbal communication in English and local language
• Working Knowledge of computer systems including Microsoft Word, Excel, Outlook and PowerPoint
• Communicative skills
• Active team player

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.