Global Clinical Trial Support - Managed Access - Home Based (US)

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

What you will be doing:

• Schedules study management team meetings for each project assigned and maintains documentation from meetings in appropriate repository.
• 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 up- to-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.
• Continuous and up-to-date understanding of the study, processes and system/documentation requirements ensuring ongoing inspection readiness by complying with relevant training requirements.
• With focus on quality, supports on an ongoing basis the GTL, TM, GPL and Quality Assurance (QA)
  team with audit findings report and CAPA management.
• In complete partnership with the study team through the GTL, TM interactions, ensures timely document preparation and submission and approval tracking (and hence compliance with local regulatory requirements) for IEC/HA approvals, if applicable.
• Full utilization by timely and accurate time reporting.

You are:

• Bachelor’s degree. Degree in a health or science related field preffered
• Excellent independent time management skills.
• Experience in clinical research experience in the pharmaceutical industry or CRO.
• Experience with regulatory documents
• Global trial experience highly preferred 
• Literacy and proficiency in IT skills with appropriate software and company systems.
• 1-3 years relevant work experience; however, other relevant experiences and skills may be considered.
• Excellent decision-making skills and understanding of escalating appropriately
• Proficient communication skills (at all levels)
• Fluid thinker
•  
• To qualify, applicants must be legally authorized to work in the United States  and should not require, now or in the future, sponsorship for employment visa status

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, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. 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. 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.