Evaluator - Clinical Trial Methodology
il y a 2 semaines
**Sciensano **is het instituut ontstaan uit de samensmelting van het Wetenschappelijk Instituut voor Volksgezondheid (WIV-ISP) en het Veterinair en Agrochemisch Onderzoekscentrum (CODA-CERVA). Onze instituten hebben hun krachten gebundeld om de gezondheid van mens en dier beter te begrijpen. Sciensano ondersteunt het gezondheidsbeleid door innovatief wetenschappelijk onderzoek, analyses, surveillance en expertadvies.
Samen met meer dan 850 medewerkers werken wij mee aan meer dan 100 wetenschappelijke projecten gefinancierd door overheden, Belgische of internationale partners en opdrachtgevers. Zo dragen we bij tot een langer gezond leven voor iedereen.
**Functiebeschrijving**
Je ondersteunt de directie "PRE" van het federaal agentschap voor geneesmiddelen en gezondheidsproducten (FAGG), die de ontwikkeling van een geneesmiddel opvolgt tot het moment van de initiële vergunning voor commercialisatie.
Je evalueert het protocol en de methodologie van klinische proeven in het kader van aanvragen tot de uitvoering van klinische studies en wetenschappelijke adviezen (nationaal en Europees).
Je stelt een adviserend rapport op over het protocol en de methodologie van de klinische proef.
Je verleent wetenschappelijke adviezen en verdedigt de standpunten in het kader van strategische beslissingen binnen je expertisedomein.
Daarnaast neem je deel aan nationale en internationale vergaderingen waar je de standpunten van België verdedigt.
Je ontwikkelt je expertise binnen je vakgebied en stelt ze ter beschikking van het FAGG en andere betrokkenen.
Je werkt in een dynamische multidisciplinaire omgeving.
Jouw bijdrage zorgt voor de veiligheid en doeltreffendheid van innovatieve geneesmiddelen.
**Profiel**
Master in de bio
- of medische wetenschappen
Ervaring : min. 4 jaar relevante ervaring in het domein van de klinische studies (methodologie)
Zeer goede kennis van: methodologie van klinische studies; legale verplichtingen en regelgeving van klinische proeven; GCP
Talen : Nederlands of Frans en een degelijke kennis van de Engelse taal (mondeling en schriftelijk)
Troeven : ervaring met de evaluatie van protocollen van klinische proeven; publicaties in wetenschappelijke tijdschriften
Generieke competenties : evalueren en beslissen; beïnvloeden, onderhandelen en overtuigen; samenwerken en delen van inzichten; leergierig en wetenschappelijk gedreven; plannen en organiseren; stressbestendig; verantwoordelijk; resultaat
- en klantgericht; opbouwen van relaties en netwerken
**Wij bieden**
Een uitdagende functie in een bekend wetenschappelijk instituut
Arbeidsovereenkomst van onbepaalde duur
Weddeschaal : SW1 of SW2
Voordelen : gratis abonnement of 100% terugbetaling woon-werkverkeer met het openbaar vervoer; hospitalisatie
Andere : glijdende werkuren in een 38-uren week; mogelijkheid tot telewerk en opleidingen
**Contact**
Heb je vragen omtrent deze functie of wens je bijkomende informatie?
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