Clinical Research Manager

il y a 2 semaines

Anvers, Belgique Jefferson Wells Belgium Temps plein

Clinical Research Manager Contracting – Antwerpen Verantwoordelijkheden Plannen, beheren en opvolgen van de dagelijkse activiteiten binnen klinische studies. Zorgen dat alle activiteiten in overeenstemming zijn met de geldende veiligheidsvoorschriften, procedures en kwaliteitsnormen (GCP/GxP). Volledig beheer van Investigator Sponsored Studies (ISS) en optreden als contactpersoon met de studiecentra. Implementeren van studieparameters, deliverables, beleid en resourceplanning. Toepassen van wetenschappelijke discipline om risico's te minimaliseren en de prestaties te optimaliseren. Samenwerken in cross-functionele teams voor de evaluatie van nieuwe productideeën en de uitvoering van businessstrategieën. Beheren van de analyse en documentatie van klinisch werk om de marktkansen van producten te beoordelen. Evalueren en documenteren van de resultaten van fase I–IV onderzoeken ter voorbereiding van registratieaanvragen bij regelgevende instanties. Rapporteren van bevindingen aan het senior management en indienen van rapporten, registraties en submissies. Beoordelen van interne en externe onderzoeksvoorstellen met betrekking tot producten van het bedrijf. Voorbereiden en beheren van jaarbudgetten, inclusief operationele en kapitaalkosten. Aansturen, opleiden en evalueren van medewerkers, en zorgen dat zij over de juiste middelen en begeleiding beschikken. Leveren van technische en wetenschappelijke expertise bij het opstellen van klinische ontwikkelingsplannen. Profiel Masterdiploma in een wetenschappelijke of medische richting (Farmacie, Biomedische Wetenschappen, Bio-ingenieur, Geneeskunde, ...). Minstens 3–5 jaar ervaring in klinisch onderzoek of in een farmaceutische omgeving. Grondige kennis van Good Clinical Practice (GCP), wet- en regelgeving en kwaliteitsmanagementsystemen. Sterke projectmanagementvaardigheden met ervaring in budgetbeheer en resourceplanning. Communicatief sterk en in staat om te functioneren binnen multidisciplinaire teams. Analytisch, nauwkeurig en resultaatgericht, met oog voor kwaliteit en compliance. Vloeiend in Nederlands en Engels, zowel mondeling als schriftelijk. Our offer? Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You're interested in this job? We kindly invite you to apply or send me your CV, jason.devillers@jeffersonwells.be

  • Clinical Research Manager

    il y a 2 semaines

    Anvers, Belgique Jefferson Wells Belgium Temps plein

    Clinical Research Manager Contracting – Antwerpen Plannen, beheren en opvolgen van de dagelijkse activiteiten binnen klinische studies. Volledig beheer van Investigator Sponsored Studies (ISS) en optreden als contactpersoon met de studiecentra. Samenwerken in cross-functionele teams voor de evaluatie van nieuwe productideeën en de uitvoering van...

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