Clinical Research Associate (f/m/d) EMEA

ZOLL Medical Corporation; Köln; Remote; EUR 50.000 - 70.000; Vollzeit

Zusammenfassung

A leading medical technology company is seeking a motivated Clinical Research Associate to support the execution and monitoring of clinical trials. You will ensure the integrity of clinical research projects and collaborate with cross-functional teams. The ideal candidate holds an MS/PhD, has over 3 years of experience, and is proficient in English and another European language. This position offers flexible working hours and significant training opportunities.

Leistungen

30 days annual leave

Flexible working hours

Training opportunities

Corporate benefit discounts

Health management program

Qualifikationen

• 3+ years of experience in the medical industry, ideally in clinical research.
• Cardiology experience preferred.
• Fluent in English and one other Major European language.

Aufgaben

• Monitor and manage clinical research projects.
• Act as a liaison with clinical sites.
• Prepare study-related documents and ensure compliance.

Kenntnisse

Clinical trial management

Medical terminology

Presentation skills

Proficiency in English

Knowledge of GCP guidelines

Ausbildung

MS/PhD in a clinical or scientific field

Tools

Microsoft Word

Microsoft Office

Microsoft Excel

Microsoft Project

Jobbeschreibung

Overview

The Cardiac Management Solutions division of ZOLL Medical Corporation develops products to protect and manage cardiac patients, including the LifeVest wearable cardioverter defibrillator (WCD), the ZOLL cardiac monitor, and associated technologies.

The LifeVest is a wearable defibrillator worn by patients at risk for sudden cardiac arrest (SCA), providing protection during their changing condition and while permanent SCA risk has not been established. The LifeVest allows a patient’s physician time to assess their long-term arrhythmic risk and make appropriate plans.

Position

Our EMEA team is looking for a dedicated and motivated Clinical Research Associate (CRA) to support us in the execution and monitoring of clinical trials. In this role, you will play a key part in ensuring the quality and integrity of our clinical research projects from planning through to implementation.

Clinical Research Associate (f/m/d) EMEA home based

(full time / unlimited)

Responsibilities

• Monitoring and site management activities for clinical research projects
• Acting as a company liaison, work with clinical sites to resolve any site related issues quickly and effectively
• Preparing of study related documents including but not limited to informed consent forms, note to file, etc.
• Monitor ongoing compliance to study protocols and site adherence to global regulatory guidelines, including safety reporting
• Responsible for the distribution, collection and tracking of regulatory documentation and support regulatory submissions
• Support clinical operations management in project management
• Partner with cross-functional teams (EMEA and US) such as data management and medical affairs with query management, data reviews and resolution
• Coordinate or manage multiple projects across multiple centers and countries
• Travel to study sites based on project needs
• Performs other duties as assigned by Management
• Ability to travel up to 65%, based on project needs, including national and international conferences and responsibilities
• Participate in research meetings including presentations at those meetings

Experience and Personal Qualities

• MS/PhD in a clinical, scientific, or related field; and ideally 3 years plus experience in medical industry
• Cardiology experience preferred
• Strong working knowledge of medical/scientific terminology and working knowledge of Ministry of Health regulations and GCP guidelines is required
• Knowledge of legal and regulatory landscape concerning clinical research
• Professional use of the English language, both written and oral and one other Major European language (preferably French, Italian or Spanish)
• Demonstrated proficiency in implementing, monitoring, and management of clinical trials (start-up to close-out)
• Presentation skills
• Facile in Microsoft Word, Office, Excel, and Project.

Benefits

• A varied job with plenty of development potential in a dynamic and growing medical technology market
• Flexible and convenient working hours and 30 days annual leave
• Take advantage of our numerous training opportunities and grow with us
• Benefit from various discounts on our corporate benefit portal
• Your health is important to us: benefit from our varied health management program
• Comprehensive training in your area of responsibility is a matter of course for us

If this opportunity is of interest to you, we look forward to receiving your application documents.

Question? If you are unsure whether your qualifications are suitable or would like further information about the position, please give me a call.

Your contact is Anja Preuße, Senior HR Business Partner.

You can reach me by phone on [phone] or by email at [e-mail].