2 дня назад
Experienced Clinical Trials Assistant (Clinical Research)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Experienced Clinical Trials Assistant (Clinical Research) (Clinical Research): Supporting the preparation, documentation, tracking, and archiving of clinical research projects and Trial Master Files with an accent on clinical documentation, data flow, and collaboration with CRAs and regulatory start-up teams. Focus on maintaining study compliance records, coordinating clinical trial supplies and case report forms, and ensuring complete and accurate project documentation.
Location: Home-based in Germany, with the position listed in Frankfurt, Hesse; flexibility to visit the client’s office if needed and occasional support during CRA site visits may be required.
Company
provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.
What you will do
- Support CRAs and Regulatory and Start-Up teams in updating and maintaining clinical documents and systems, including Trial Master Files.
- Prepare, distribute, file, archive, and periodically review clinical documentation and reports.
- Coordinate clinical trial supplies, tracking information, Case Report Forms, queries, and clinical data flow.
- Act as a central contact for project communications, correspondence, and associated documentation.
- Contribute as a subject matter expert to business processes and departmental quality or process improvement initiatives.
- Occasionally accompany CRAs on site visits to assist with clinical monitoring after completing the required training.
Requirements
- Bachelor’s or higher-level degree in life science, or a high school diploma with relevant apprenticeship experience in life science, medical, pharmaceutical, or office management.
- 2–4 years of administrative support experience in clinical research, such as Clinical Trials Assistant, Project Assistant, in-house CRA, or Study Start-Up Assistant.
- Knowledge of clinical research regulations, Good Clinical Practice, and ICH guidelines.
- German at C1 level or higher is required; good command of English is also required.
- Working knowledge of Microsoft Word, Excel, and PowerPoint.
- Strong communication, organization, planning, prioritization, and independent working skills.
Culture & Benefits
- Full-time, home-based work arrangement in Germany.
- Work within a sponsor-dedicated clinical functional service partnership team.
- Opportunity to support clinical trials across different therapeutic areas.
- Collaboration with clinical teams, research sites, internal departments, and the client.
Hiring process
- Submit an English CV and motivation letter.
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