Trial Set-up Qc Manager

Il y a 2 mois

Gent, Belgique Cerba Research Nederland Temps plein

As Trial Set-Up QC Manager you play a crucial role in ensuring that all aspects of the clinical trial are appropriately planned, documented, and executed to meet regulatory requirements and maintain data integrity.

The Trial Setup QC Manager performs the study set-up, Quality check of all site documents and configuration in the database related to a clinical trial.

**Your tasks & 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.

**To succeed in this role, you bring a combination of skills, experiences, and characteristics**:

- A Bachelor's degree
- Excellent attention to detail, accurate administrator
- Planning Skills
- You are highly conscientious and diligent
- Flexibility in dealing with problems (related to e.g. project scope, deadlines)
- Ability to communicate in a clear and direct way
- Fluent in Dutch and English

**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

**If you have drive, are willing to learn and want to make an impact, then please join

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