Trail Master File Specialist (m/f/d)
Responsibilities
- Strategic management of the document lifecycle in eTMF: creation, versioning, review, approval and archiving - always in line with regulatory requirements and study timelines
- Quality control (QC) and review of study documents to ensure GCP compliance
- Participation in the development and optimization of SOPs, work instructions and forms in the eTMF environment
- Regular review of the completeness and quality of the TMF in accordance with the TMF plan
- Support with audits and inspections
- Coordination of digitization and integration of paper-based and external TMFs
- Administrative tasks in the eTMF system, e.g. user administration and maintenance of global directories
Profile
- Degree in life sciences, healthcare or comparable qualification
- Solid experience in the documentation of clinical studies (e.g. as TMF Specialist or CTA)
- Profound knowledge of ICH-GCP and eTMF systems
- Structured, detail-oriented way of working and strong organizational skills
- Confident use of MS Office and good written and spoken communication skills
Benefits
- Varied tasks in a renowned company
- You will work in an international environment
- Possibility of extension
About Hays
With over 15 years of experience in the pharmaceutical and chemical industry as well as in biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge. Register with us and reap the benefits of interesting job offers that match your skills and experience.
Staffing process for freelance specialists
- Analysis of qualifications
- Telephone or personal interview
- Contact with customers
- Contract with Hays
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1. Analysis of qualifications
We carry out a detailed analysis of your technical qualifications on the basis of your CV, your application documents and your profile.
Contact at Hays
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