Trial Setup Manager - Zwijnaarde

12-3-2020 zwijnaarde
company profile

We are searching for a Trial Setup Manager who will perform day-to-day operational tasks during the setup of a trial for a well known clinical laboratory. They provide the highest quality specialized laboratory and diagnostic solutions while leveraging patient data and scientific insight
to shape and advance clinical trials. With their global footprint and access to leading regional labs, data, patients, technology, and partnered
resources, they support global biotech, pharma, and IVD organizations to improve the lives of patients around the world.

job description

Documentation of the complete setup in a Trial Master File part Set-Up (creation, maintenance
and archiving)

Preparation of sponsor study documentation:
- Preparation of the Laboratory Specifications, describing the services foreseen in a
specific project, based on the Trial Notification Form, clinical study protocol, study
budget and communication with the sponsor
- Preparation of Central Laboratory Study Documentation

Preparation of site study documentation:
- Preparation of Central Laboratory manuals and the English instruction leaflet
- Coordinate the translation of leaflets if required
- Preparation of the study specific requisition forms
- Preparation of other site documentation (eg Sampling Material Request form, Request
for dry ice form, Sample log form)
- Upload of site study documentation on the Board

Preparation of internal study documentation:
- Local trial set-up (NWHL, Cerba, Histalim, subcontracted labs, ¿)
- Preparation of the internal study start up document to provide all departments with
trial specific directives as established in agreement with the sponsor (MIPS trials only)

Technical preparation of the study database:
- Follow-up on test code creation in Master Test Catalogue
- Initiation and finalization of study-specific reference ranges
- Preparation of CTMS Study Set-up configuration
- Cross-review (upper layer QC) sponsor/site/internal study documentation and technical database
- Perform other tasks deemed necessary to assure good quality work according to standard
operating procedures and agreements made with the sponsors

Only applicable for srTSM role:
- Assist in making sure Standard Operation Procedures, process flows and templates are in place to
achieve local and global transparency and quality
- CTMS set-up superuser (assist Global Process Owner trial set-up in change and issue
management, UAT and training of the other users)
- Mentor and training of new employees

your contribution

- Bachelor degree (office management languages/medical or science oriented)
- Accurate administrator
- Flexible in dealing with problems (related to eg project scope, deadlines)
- Good communication skills
- Thorough knowledge of standard computer and office applications
- Fluent in Dutch and English, notions French

Do you recognize yourself in this description? Send your cv to!

what do we offer?

What do we offer?
A challenging job with a nice salary!

administrative employee (m/f)
employment type
full time
contract type
immediate permanent employments
Gezondheidszorg en maatschappelijke dienstverlening
your Randstad contact
Peggy, Ruth & Florine 09/269.98.75 of
09/269.98.75 of

office info
Gent Brabantdam 70
Brabantdam 70
9000 GENT