CTA

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

What you will be doing:

• Partners with the TM and SM to ensure overall study and site management and adherence to internal SOPs, policies and country regulatory requirements.
• Supports the study team in performing study feasibility and site assessments.
• Assists TM in management of study budget including Affiliate spend, vendor management (including reconciliation of invoices and final budget), liaising with Accounts Payable as necessary
• Maintains trial, country, and site level protocol information in Trial Management Systems (e.g. CTMS, TMS, etc.).
• In liaison with the TM ensures current versions of the required trial documents, trial-related materials and supplies are provided to the investigational site(s) within required timeframes.
• Where applicable, works with investigational site staff to ensure accurate/complete regulatory documents are in place to expedite IEC/IRB or Health Authority (if applicable) approval process.
• Supports the TM or, where applicable the SM, in providing the current and complete documents requested by the IEC/IRB and HA.
• Supports the TM and SM collecting and maintaining all documents throughout the trial and post trial documents in both e-TMF and paper files and complete final reconciliation at the end of the trial.
• If applicable supports study specific SharePoint sites to ensure availability of trial documents to the study team
• If applicable supports the TM in the organization and management of meetings (i.e. takes minutes, follow up on action completion)
• If applicable supports TM in organization of training for SM(s) and/or small investigator meetings
• Distributes, collects, reviews, and tracks regulatory documents, agreements and training documentation.
• Collects and tracks Financial Disclosure information at appropriate time points.
• May contribute to process improvement
• Complies with relevant training requirements.
• Supports TM with providing study information to vendors (e.g. site contact list, …)
• Helps to ensure inspection and audit readiness

You are:

• Bachelor Degree- University in Life Sciences, Nursing, or related scientific field preferred.
• Skills set corresponding with 0-2 years relevant clinical trial experience is preferred, however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.
• Proficient in English language. Strong knowledge with MS Office (Word, Excel, Access, Outlook, Explorer and PowerPoint). Strong interpersonal and negotiating skills. Excellent organizational skills and the ability to collaborate and handle multiple priorities within a matrix environment. Perform activities in a timely and accurate manner

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/benefitsICON, including subsidiaries, is an equal opportunity and inclusive employer and 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 or submit a request here.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.