Experienced Clinical Trials Assistant (m/w/d), based in Düsseldorf

IQVIA; Frankfurt; Hybrid; EUR 40.000 - 60.000; Vollzeit

Zusammenfassung

A leading global provider of clinical research services is seeking an Experienced Clinical Trials Assistant to join their team in the Düsseldorf area. This full-time role offers a hybrid work model combining office and home-office. The position involves assisting with clinical documentation, ensuring compliance with regulatory standards, and requires fluent language skills in German (C1) and good command of English. Join a company dedicated to your development and success.

Qualifikationen

• 2+ years of experience in clinical research or administrative roles.
• Knowledge of GCP and ICH guidelines.
• Ability to prioritize tasks in a clinical environment.
• Flexibility for site visits in Düsseldorf.

Aufgaben

• Assist with updating and maintaining clinical documents and systems.
• Prepare, file, and archive clinical documentation.
• Review study files for completeness and manage clinical data flow.
• Act as a contact for project communications.
• Accompany CRAs on site visits after training.

Kenntnisse

Clinical Trials Assistant experience

Regulatory compliance knowledge

Effective communication

Organizational skills

Independence in work

Fluent German (C1 level)

English proficiency

Microsoft Office skills

Ausbildung

Bachelor’s degree in life sciences or relevant field

High School Diploma with apprenticeship

Jobbeschreibung

Overview

The IQVIA sponsor-dedicated Clinical Functional Service Partnerships (Clinical FSP) department is supporting our client’s project team in the execution of clinical trials. Joining the team provides the opportunity to work with the preparation and documentation of clinical research projects in different therapeutic areas. You will be involved in data management, creation of study related documents and correspondence with internal departments, research sites and our client to ensure a complete and accurate Trial Master File delivery.

We currently offer the exciting opportunity to join the team as Experienced Clinical Trials Assistant (m/w/d) in full-time and work in a combination of office and home-office in the Düsseldorf area.

Responsibilities

• Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines.
• Assist the clinical team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
• Assist with periodic review of study files for completeness. Assist CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
• Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.
• Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.
• May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training.

Required knowledge, skills and experience

• Bachelor’s or higher-level degree preferable in life science or High School Diploma and apprenticeship in life science, the medical or pharmaceutical field or office management.
• At least 2 years of experience as Clinical Trials Assistant or in another administrative role in clinical research, e.g. as Project Assistant.
• Excellent knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Fluent language skills in German at least C1 level and good command of English.
• Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint.
• Effective communication, organizational and planning skills.
• Ability to work independently and to effectively prioritize tasks and to maintain effective working relationships with coworkers, managers and clients.
• Flexibility to visit our client's office for meetings in the Düsseldorf area on a regular basis, about 2-3 days/week.

We invite you to join IQVIA.

Why join us?

Ongoing development is vital to us enabling you to have the opportunity to progress your career, with the potential to move into other related areas to enhance your skill set. Our benefits package is competitive, our scope is international, and we genuinely care about our people and their success.

Whatever your career goals, we are here to ensure you get there!

Please apply with your English CV, motivation letter and your certificates and reference letters.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com