Clinical Trials Assistant (CTA) - sponsor dedicated

Pharmaceutical Research Associates, Inc; Deutschland; Vor Ort; EUR 35.000 - 55.000; Vollzeit

Zusammenfassung

An established industry player is seeking a Clinical Trials Assistant to support the coordination and administration of clinical studies. This office-based role in Langen, Germany, involves ensuring quality and consistency in study deliverables. The ideal candidate will possess strong organizational and administrative skills, along with fluency in both German and English. The company offers a competitive salary and a variety of benefits focused on well-being and work-life balance, making it an exciting opportunity for those looking to make a meaningful impact in the medical field.

Leistungen

Annual Leave Entitlements

Health Insurance Options

Retirement Planning Options

Employee Assistance Programme

Life Assurance

Gym Discounts

Childcare Vouchers

Travel Passes

Qualifikationen

• High school qualifications supporting skills for the role.
• Previous administrative experience in medical or life sciences preferred.

Aufgaben

• Assist in the coordination and administration of clinical studies.
• Ensure timely submission of applications and documents to authorities.
• Maintain operational responsibility for local eTMF and ISF.

Kenntnisse

Organizational Skills

Administrative Skills

Computer Skills

Fluent in German

Fluent in English

Ausbildung

High School Diploma

Jobbeschreibung

Overview

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

This is an office-based role located in Langen, Germany.

Responsibilities

What you will be doing:

• Assist in the coordination and administration of clinical studies from start-up to close-out.
• Collect, prepare, review, and track documents for the application process.
• Ensure timely submission of proper applications and documents to EC/IRB and regulatory authorities throughout the study.
• Interface with Investigators, external service providers, and CRAs during document collection to support effective study delivery.
• Serve as the local administrative main contact, working closely with CRAs and LSAD throughout the study.
• Maintain operational responsibility for the setup and upkeep of the local eTMF and ISF, including document tracking in accordance with ICH-GCP and local requirements.
• Ensure essential documents are uploaded timely to maintain eTMF inspection readiness.
• Prepare study documents for final archiving and support CRA in study close-out activities.
• Contribute to the production and maintenance of study documents, ensuring template and version compliance.

Qualifications

You are:

• Possessing high school/secondary school qualifications that support your skills and capabilities for the role.
• Having previous administrative experience, preferably in the medical or life sciences field.
• Proven organizational and administrative skills.
• Proficient in computer skills.
• Fluent in spoken and written German and English.
• Willing and able to work at the office in Langen, Germany.

What ICON can offer you:

Our success depends on the quality of our people. We are committed to building a diverse culture that rewards high performance and nurtures talent. In addition to a competitive salary, ICON offers a range of benefits focused on well-being and work-life balance, including:

• Various annual leave entitlements
• A range of health insurance options
• Retirement planning options
• Global Employee Assistance Programme, TELUS Health, providing 24-hour support
• Life assurance
• Flexible, country-specific benefits such as childcare vouchers, bike schemes, gym discounts, travel passes, and health assessments

Visit our careers website to learn more about working at ICON: https://careers.iconplc.com/benefits

ICON values diversity, inclusion, and belonging. We are committed to providing an accessible environment and equal employment opportunities for all candidates. If you require reasonable accommodations during the application process or in performing job functions, please inform us through the provided contact channels.

We encourage you to apply even if you do not meet all the listed requirements, as you may still be the right fit for this or other roles at ICON.

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