Clinical Development Administrator

il y a 2 semaines


Gent, Flandre, Belgique Oxford Global Resources Temps plein
**Clinical Development Administrator**:

- Location:
Ghent, Belgium
- Contact:
Thomas De Naegel
- Job type:
Temp to Perm
- Contact phone:

- Industry:
Clinical Research

Ben jij een gedreven en gemotiveerde professional met een passie voor biotechnologie en een sterk gereguleerde omgeving? Onze klant, een toonaangevend bedrijf in de diagnostische sector, zoekt een Clinical Development Administrator om het dynamische team te versterken. In deze sleutelrol speel je een essentiële rol bij het voldoen aan de wettelijke vereisten voor in-vitro diagnostische hulpmiddelen (IVD's).

**Functieomschrijving**:
Dankzij de gedrevenheid en betrokkenheid van de medewerkers levert onze klant innovatieve oplossingen aan de wereldwijde gezondheidszorg. Hun diagnostische testen, ontwikkeld en geproduceerd in Gent en Tokio, stellen artsen in staat snel en accuraat diagnoses te stellen in verschillende ziektedomeinen. Word lid van deze internationale familie en draag bij aan het bieden van de beste oplossingen in de diagnostische sector.

**Verantwoordelijkheden**:
IVDR Dossierbeheer:

- Bijdragen aan de voorbereiding en indiening van IVDR dossiers.
- Coördineren van klinische studies voor IVD-productontwikkeling.
- Nakijken en standaardiseren van protocollen om te voldoen aan wettelijke normen.
- Samenwerken met cross-functionele teams voor gegevensauthenticatie.
- Assisteren bij de ontwikkeling en onderhoud van gebruiksaanwijzingen (IFU).
- Onderhouden en bijwerken van IVDR-bestanden.
- Zoeken naar literatuur met betrekking tot assayprestaties en regelgevende updates.

Biobank Beheer:

- Beheren van biobankactiviteiten, inclusief staalservice, aanvragen opvolgen en leveringen coördineren.
- Afhandelen van Human Biological Materials overeenkomsten (HBM) en data privacy overeenkomsten.
- Toezien op correcte verzending van biologische materialen, inclusief douanevrijgave.
- Administratie van biobankdatabase met betrekking tot stalen en studies.

**Profiel**:

- Je hebt een bachelor/master diploma in medische of wetenschappelijke richting of gelijkwaardig door ervaring.
- Je toont sterke interesse en/of ervaring met biotechnologie in een sterk gereguleerde omgeving.
- Je bent accuraat en administratief vaardig.
- Je hebt uitstekende schriftelijke en mondelinge communicatievaardigheden in het Engels en Nederlands.
- Je bent vaardig in het schrijven van technische/wetenschappelijke rapporten.
- Je hebt een goede kennis van MS-office Word en Excel.

**Arbeidsvoorwaarden**
- Een boeiende job bij een multinational
- Een marktconform loon

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