Trial Set-up Qc Manager

il y a 2 semaines


Gent, Belgique Viroclinics-DDL Temps plein

As the Trial Setup QC Manager, you perform a Quality Check of all site documents and study set-up configuration in the database related to a clinical trial.

We are Cerba Research, a global partner for integrated clinical laboratory and diagnostic solutions. We help accelerate therapies through the development of highly specialized custom assays, deep biomarker expertise, and a passion for scientific innovation across complex therapeutic areas.

**It is our mission to improve global health, together with our highly valued employees. Do you want to be part of our mission and join in the role of Trial Set-Up QC Manager?**

**Your responsibilities**:
Trial specific documents should be QC’ed before finalization:

- QC of trial specific documentation (external):

- Central Laboratory Study Documentation
- Site study documentation: Central Laboratory manual and the instruction leaflet (ENG), Sampling Material Request form, Request for dry ice form
- Other trial documents requested during trial set-up.
- QC of trial specific documentation (internal):

- Local trial set-up (NWHL, Cerba, Histalim, subcontracted labs,)
- Study Set-up configuration (CTMS)
- Other trial documents requested during trial set-up

Cross-review with reference to the Laboratory Specification Document (LSD)
Create QA reports and translates valuable QA insight into actionable next steps.

Perform other tasks deemed necessary to assure good quality work according to standard operating procedures and agreements made with the sponsors.

**In order to be successfull in this job you'll need**:

- Bachelor’s degree (office management languages/medical or science oriented)
- Excellent attention to detail.
- Planning Skills
- Highly conscientious and diligent.
- Accurate administrator
- Flexible in dealing with problems (related to e.g. project scope, deadlines)
- Good communication skills
- Fluent in English, notions French and / or Dutch

**Working at Cerba Research**

Cerba Research is growing fast on a global scale. Working at Cerba Research first of all means that you contribute to improve global health. It also means growing your career in a dynamic, fast paced environment, where you can develop new skills and work on diverse projects. There is plenty of room for initiatives, we encourage you to take ownership, cooperate, keep learning and most and for all, have fun Working at Cerba Research also comes with its challenges and it’s not for everyone.

**Sounds like you? Then please apply, we would love to meet you


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