Are you experienced in working with clinical trials? Are you particularly familiar with GCP regulations and the associated validation processes? Then apply now as a "Clinical Trial Expert (m/f/d)" in the Stuttgart area!
In this position as "Clinical Trials Expert (m/f/d)" you will ensure that all GCP guidelines for the laboratory analyses of clinical trials in the Department of Clinical Biomarkers and Immuno-monitoring are adhered to. For this, you will work on SOPs, and validate software programs used in the analysis of clinical samples. Also prepare the laboratory for inspections and audits and perform CAPAs.
- Ensure that all GCP guidelines are established and followed in the department;
- Validate the laboratory equipment and laboratory software used in the evaluation of clinical samples;
- Coordinate maintenance and possible repair of laboratory equipment by external contractors;
- Review and improve existing SOPs and create new ones if necessary;
- Manage the risk assessment of your department;
- Prepare your department for internal and external audits and follow up CAPAs.
- Archive important information and study results in collaboration with the responsible scientists;
- Work harmoniously with your laboratory staff, QA/QM, IT and other departments and external parties.
- You have a BSc or MSc in a relevant field of science (biology, biochemistry, life science, or similar).
- You already have relevant experience working in a bioanalytical laboratory (At least 3 years);
- Have very good knowledge about GxP regulated working environments; in particular GCP;
- Are experienced in the validation and qualification of laboratory equipment and its software systems;
- You already have some experience in the preparation of SOPs;
- Initial experience with CAPAs is an advantage;
- You need to be fluent in English; German is an advantage.
- Contract: Direct permanent employment with the client; Permanent position with 6 months probationary period;
- Salary: Depending on level of experience between 50.000€ and 65.000€ per year;
- Location: Stuttgart region;
- Working hours: Full-time (40 hours)
Job number: 20481