Clinical Trial Assistant - Hamburg

ICON Strategic Solutions; Deutschland; Vor Ort; EUR 35.000 - 45.000; Vollzeit

Zusammenfassung

ICON Strategic Solutions is seeking a Clinical Trials Assistant to support the coordination and administration of clinical study activities. In this role, you will ensure the quality and consistency of study deliverables while interfacing with various stakeholders. The ideal candidate will have prior administrative experience in the medical or life sciences field, strong organizational skills, and proficiency in both German and English. ICON offers a competitive salary and a range of benefits focused on employee well-being and work-life balance.

Leistungen

Various annual leave entitlements

Health insurance offerings

Retirement planning offerings

Global Employee Assistance Programme

Life assurance

Flexible optional benefits

Qualifikationen

• Previous administrative experience, preferably in the medical/life science field.
• Proven organizational and administrative skills.
• Good knowledge of spoken and written German and English.

Aufgaben

• Assist in coordination and administration of study activities from start-up to close-out.
• Prepare and track documents for application and submission to EC/IRB.
• Maintain the local eTMF and ensure compliance with ICH-GCP.

Kenntnisse

Organizational skills

Administrative skills

Computer proficiency

Proficiency in German

Proficiency in English

Ausbildung

High school/Secondary school qualifications

Jobbeschreibung

The Clinical Trials Assistant (CTA) assists in the coordination and administration of the study activities from the start up to execution and close out, and within the Local Study Team (LST) to ensure quality and consistency of interventional study deliverables to time, cost and quality objectives

Ø Collects, assists in preparation, reviews and tracks documents for the application process as well as coordination and tracking of study materials and equipment

Ø Assist in submission of proper application/documents to EC/IRB and, where appropriate to Regulatory Authorities

Ø Interfaces with Investigators, external service providers and CRAs during the document collection process

Ø Local administrative main contact and works closely with the CRAs and/or the CTMs for the duration of the study

Ø Set-up and maintenance of the local eTMF and ISF including document tracking in accordance with ICH-GCP and local requirements

Ø Ensures essential documents are uploaded in a timely manner to maintain the eTMF “Inspection Readiness” and study documents are ready for final archiving and completion of local part of the eTMF and supports the CRA in the close out activities for the ISF

Ø Prepares and/or supports contract preparation at a site level ( with the exception of countries where there is a specific role dedicated to preparing site contracts)

Ø Leads the practical arrangements and contributes to the preparation of internal and external meetings. Responsible for printing and distribution of documents such as letters and meeting minutes, and for handling and archiving of study/country related e-mails

Ø Interfaces with Data Management Centre and/or Data Management, Global Clinical Solutions representatives to facilitate the delivery of study related documents/material

Ø Ensures compliance with local, national and regional legislation, as applicable

• High school/Secondary school qualifications (*), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers.
• Previous administrative experience preferably in the medical/ life science field.
• Proven organizational and administrative skills.
• Computer proficiency.
• Good knowledge of spoken and written German and English

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, inclusion & belonging are fundamental to our culture and values. 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, 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 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.