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

IQVIA LLC; Basel; Vor Ort; CHF 70.000 - 90.000; Vollzeit

Zusammenfassung

IQVIA LLC in Basel is seeking an experienced Clinical Trials Assistant (m/w/d) for a full-time, on-site role in Switzerland. You will support CRA and RSU teams with TMF maintenance, documentation handling, and archiving in line with SOPs.

You will coordinate CRF tracking, data flow, and communications across departments. The ideal candidate has 2–4 years in clinical research admin, solid GCP/ICH knowledge, and strong German (C1) and English skills, along with MS Office proficiency.

Qualifikationen

• Bachelor’s or higher in life science or HSD with apprenticeship in life science or pharma.
• 2–4 years of administrative support experience in clinical research roles.
• Knowledge of GCP and ICH guidelines.
• Fluent German (C1) and good command of English.
• Proficient in Microsoft Word, Excel and PowerPoint.

Aufgaben

• Assist CRAs and RSU with updating and maintaining Trial Master File (TMF).
• Prepare, handle, file, and archive clinical documentation according to SOPs.
• Coordinate tracking of CRFs, queries and data flow.
• Support on-site visits and training of new team members.

Kenntnisse

German (C1)

English proficiency

MS Office

Ausbildung

Bachelor's degree in life sciences

High School Diploma with life science apprenticeship

Tools

MS Word

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** in **Switzerland.****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 if needed**Please apply with your English CV and motivation letter.**