Experienced Clinical Trials Assistant (m/w/d), home-based in Germany

IQVIA LLC; Frankfurt; Vor Ort; EUR 40.000 - 52.000; Vollzeit

Zusammenfassung

IQVIA in Germany is seeking an experienced Clinical Trials Assistant (m/w/d) to support project teams in clinical trials. You will help prepare and maintain TMF documents, correspond with sites and internal departments, and ensure complete trial master file delivery.

Responsibilities include updating trial documents, assisting CRAs/RSU, managing study files, and coordinating CRF tracking and data flow. Fluency in German (C1) and English, plus 2–4 years of admin experience in clinical research,

Qualifikationen

• Bachelor’s or higher in life science, or HS diploma with life science apprenticeship.
• 2–4 years administrative support experience in clinical research.
• Knowledge of GCP and ICH guidelines.
• Fluent German (C1) and good English.
• Proficiency with Word, Excel, PowerPoint.
• Strong communication, organizational and planning skills.
• Ability to work independently and prioritize across multiple projects.
• Willingness to visit client’s office if needed.

Aufgaben

• Assist CRAs and RSU with updating and maintaining TMF and project documents.
• Collaborate on preparation, filing, and archiving of clinical documentation.
• Assist with periodic review of study files for completeness.
• Coordinate tracking of CRFs, queries and data flow.
• Serve as central contact for project communications and documentation.
• Support departmental quality or process improvement initiatives.
• May accompany CRAs on site visits for monitoring duties.

Kenntnisse

Communication skills

Organizational skills

Planning skills

German (C1)

English (good)

GCP/ICH knowledge

MS Word

MS Excel

MS PowerPoint

Independent worker

Ausbildung

Bachelor’s degree in life science

High School Diploma with life science apprenticeship

Office management background

Tools

Microsoft Word

Microsoft Excel

Microsoft 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 in Germany.

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.
• May serve as subject matter expert for business processes.
• 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 if needed.

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. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.