Global Clinical Trial Assistant

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:

The Global Clinical Trial Assistant -Medical Affairs Organization( MAO ) assists with local project management activities of a clinical trial (s) (or Medical Affairs data generation activity) in a country or countries. Services/deliverables include assisting with operational aspects of assigned project(s) at the country level for end to end project management from start-up through to closeout activities. Further, services will range depending on the therapeutic area and project-specific requirements. Reports to Clinical Program Leader (CPL) or designee, and partners with the Global Trial leader (GTL) to ensure overall study delivery at the country level.

• Schedules study management team meetings for each project assigned and maintains documentation from meetings.
• Assists in management of project budgets and Affiliate spend, reconciliation of invoices, final budget and liaises with Accounts payable, as necessary.
• Ensures study (s) compliance by maintaining and updating trial management systems, Clinical Trial
• Management System (CTMS), Trial Master File (eTMF) and Trial Master Source (TMS) ensuring upto-date, complete and accurate status.
• Maintains internal project specific study sites to ensure availability of all central project documents.
• Liaises with external service providers (ESP) and contract research organizations (CRO) as needed.
• Keeps oneself inspection ready and knowledgeable for current work by complying with relevant training requirements.
• With focus on quality, supports GTL, TM, CPL and Quality Assurance (QA) team with audit findings report and CAPA management.
• Keeps the trial in compliance with local regulatory requirements by organizing and ensuring IEC/HA approvals, if applicable.
• Full utilization by timely and accurate time reporting.
• If applicable, region specific deliverables will be specified.

   

You are:

• Bachelor’s degree or equivalent experience
• Degree in a health or science related field.
• Worked in a similar role previously ideally across EMEA
• Excellent independent time management skills.
• Experience in clinical research experience in the pharmaceutical industry or CRO
• Literacy and proficiency in IT skills with appropriate software and company systems
• Minimum of 2 years clinical experience highly preferred

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

ICON, 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.