Business Operations Coordinator

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:

• Open and manage Change Controls in TrackWise.
• Open and manage Quality Investigations in TrackWise
• All document uploads, EDL settings, Annual/Final Quality Reviews, responding to general V-TMF questions coming in from trial teams.​​​​​​​​​​​
• Preparation of IMPA V1 and updates to subsequent versions
• Preparation of MLS V1 and updates.  CSC Support Team to sign off as peer review
• Upload to V-TMF for P&L additional labeling and expiry update procedures
• Upload documents to V-TMF
• vTMF Quality Reviews:  Completion of the AQR to be communicated to the RTSM Manager, and inform the RTSM Manager of any findings during the Quality review.
• Upload distribution plans to V-TMF and manage V-TMF Content

You are:

• Bachelor’s degree or equivalent experience
• Experience working in a clincal enviroment or healthcare in similar roles
• Experience with Microsoft office packages Word, SharePoint, Outlook and PowerPoint is required. Strong understanding and experience with Microsoft Excel is preferred
• Experience using financial management system for procurement activities
• Knowledge in drug development, global clinical operations, and strategic planning is 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

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.

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