Experienced Clinical Trials Assistant (m/w/d), Vienna

IQVIA; Wien; Hybrid; EUR 30.000 - 36.000; Vollzeit

Benefits dieser Stelle

Hybrid work model

Office in Vienna

Zusammenfassung

IQVIA in Vienna offers a sponsor-dedicated Clinical FSP team role as an experienced Clinical Trials Assistant (m/w/d) in full-time. The position blends office work in Vienna with home-office flexibility and involves supporting TMF and regulatory processes.

You will assist CRAs and RSU, prepare and archive clinical documentation, coordinate study materials, and mentor junior staff while ensuring timely, compliant deliverables in a dynamic clinical research environment.

Qualifikationen

• Bachelor’s or higher in life science or equivalent combination with apprenticeship.
• 2–4 years of administrative support in clinical research.
• Knowledge of GCP and ICH guidelines.
• Fluent German (C1) and good English.
• Proficient MS Word, Excel and PowerPoint.
• Strong communication and organizational skills.

Aufgaben

• Assist CRAs and RSU with TMF and document maintenance.
• Prepare, handle, file and archive clinical documentation per SOPs.
• Review study files for completeness.
• Coordinate Clinical Trial Supplies and tracking information.
• Track CRFs, queries and data flow.
• Serve as central contact for project communications.
• Mentor less experienced team members and assist onboarding.
• May lead study teams and participate in process improvements.
• Occasionally accompany CRAs on site visits after training.

Kenntnisse

Administrative support

Clinical documentation

GCP/ICH knowledge

German (C1)

English proficiency

MS Office

Ausbildung

Life science degree

High School + life science apprenticeship

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Jobbeschreibung

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 sponsor dedicated team as experienced Clinical Trials Assistant (m/w/d) in full-time and work in a mixture of office-based in Vienna and in home-office.

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.
• Collaborate with clinical team on 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 and completeness.
• Collaborate with CRAs and RSU on the preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
• Coordinate 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.
• Act as a mentor for less experienced Clinical Trial Coordinators and assist with training and onboarding of new colleagues.
• May serve as subject matter expert for business processes.
• May lead Clinical Trial Coordinators study teams.
• May participate in departmental quality or process improvement initiatives.
• May occasionally 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.
• 2-4 years of administrative support experience in clinical research, e.g. as Clinical Trials Assistant, Project Assistant, inhouseCRA, Study Start-Up Assistant.
• Knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Fluent languages skills in German on 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 while working on multiple projects.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
• Flexibility to visit our client's office within the Vienna region on a regular basis.

Monthly gross salary: starting at 3.000 EUR basic - an overpay according to skills and working experience is possible.

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

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.