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:

• Trial Master File (TMF) creation and management.

• Co-ordinate entry and maintain local data into study management systems including setting up new studies.

• Ensure collection, review, track and provision of appropriate clinical documents to support regulatory submission.

• Track and maintain adequate study related supplies in the office and facilitate their distribution to sites, including preparing and distributing Study File Binders and Site Initiation presentations/materials.

• Process, reconcile, distribute and track essential documents and submit them to local archive in compliance with SOPs.

• Complete tracking documentation as applicable including but not limited to spreadsheets, study and contract tracker.

• Prepare and review site communication documents.

• Set-up/maintain courier accounts and organize shipments.

You are:

• Proficient in speaking and writing German and English

• Previous experience in clinical research

• Excellent organization skills.

• Ability to work well in a dynamic environment and able to prioritize and respond to changing needs of the business.

• Proficient Microsoft Office applications and use of Internet.

This is a hybrid position - 3 days from home, 2 days in the office in Nüremberg

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.

What you will be doing: • Trial Master File (TMF) creation and management. • Co-ordinate entry and maintain local data into study management systems including setting up new studies. • Ensure collection, review, track and provision of appropriate clinical documents to support regulatory submission. • Track and maintain adequate study related supplies in the office and facilitate their distribution to sites, including preparing and distributing Study File Binders and Site Initiation presentations/materials. • Process, reconcile, distribute and track essential documents and submit them to local archive in compliance with SOPs. • Complete tracking documentation as applicable including but not limited to spreadsheets, study and contract tracker. • Prepare and review site communication documents. • Set-up/maintain courier accounts and organize shipments. You are: • Proficient in speaking and writing German and English • Previous experience in clinical research • Excellent organization skills. • Ability to work well in a dynamic environment and able to prioritize and respond to changing needs of the business. • Proficient Microsoft Office applications and use of Internet. This is a hybrid position - 3 days from home, 2 days in the office