Clinical Development Administrator New

Il y a 5 mois


Gent, Belgique Oxford Global Resources Temps plein

Location:
Ghent, Belgium
- Contact:
Thomas De Naegel
- Job type:
Temp to Perm
- Contact phone:
+32 15284045
- 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



  • Gent, Belgique Oxford Global Resources Temps plein

    **Clinical Development Administrator**: - Location: Ghent, Belgium - Contact: Thomas De Naegel - Job type: Temp to Perm - Contact phone: +32 15284045 - 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...


  • Gent, Belgique MindCapture Temps plein

    CLINICAL OPERATIONS DEVELOPMENT LEAD - Biotech- Ghent & remoteWHAT IS OFFERED The Clinical Operations Development Lead plays a critical role in ensuring the success of clinical trials and the development of new therapeutic assets, coordinating efforts across various functions and stakeholders to drive effective clinical development strategies. Next to a...


  • Gent, Belgique Argenx Temps plein

    For the expansion of our Global Clinical Trial Operations team, argenx is looking for a Clinical Operations Development Lead. Key Accountabilities/Responsibilities: The Clinical Operations Development Lead (CODL) is responsible for the oversight of the clinical related activities within a specific therapeutic indication for an asset (CODL) or across all...


  • Gent, Belgique Argenx Temps plein

    Due to the exponential growth of argenx worldwide, we are currently looking for several _Clinical Operations Development Leads (CODL) _to strengthen the Global Clinical Trial Operations team. Ideally, location would be based in Belgium._ - The Clinical Operations Development Lead is responsible for the oversight of the clinical related activities within a...

  • Site Administrator

    Il y a 7 mois


    Gent, Belgique Cerba Research Nederland Temps plein

    As **Site Administrator **you are responsible for the day-to-day operational tasks to support the Project Management team with Clinical Trials. The Site Administrator is part of site response team. **Your responsibilities will be**: *** Manual results entry into the Clinical Trial Management system (CTMS); - Follow internal procedures to complete manual...


  • Gent, Belgique MindCapture Temps plein

    FRANCHISE CLINICAL OPERATIONS DEVELOPMENT LEAD - Biotech- GhentWHAT IS OFFERED Franchise Clinical Operations Development Lead plays a critical role in overseeing the operational path for all indications within a franchise. Functioning as a line manager, and ensuring consistency to synergy across different indication teams. The Franchise Clinical Operations...


  • Gent, Belgique Argenx Temps plein

    We are currently looking for a clinical/translational scientist with working experience in the laboratory to join our R&D team in our facility in Gent/Zwijnaarde. This scientist will combine knowledge acquired from laboratory-based research with clinical and biomarker research on human samples, with the aim to improve the treatment of patients and boost our...

  • Clinical Scientist

    Il y a 7 mois


    Gent, Belgique Argenx Temps plein

    For the expansion of our Clinical team, argenx is looking for a Clinical Scientist who directs the planning and implementation of clinical programs to meet corporate and clinical research goals. He/she will be the primary clinical/scientific contact for one or multiple clinical studies and provides clinical research expertise within the cross-functional...

  • Clinical Scientist

    Il y a 3 mois


    Gent, Belgique Argenx Temps plein

    For the expansion of our Clinical team, argenx is looking for a Clinical Scientist who directs the planning and implementation of clinical programs to meet corporate and clinical research goals. He/she will be the primary clinical/scientific contact for one or multiple clinical studies and provides clinical research expertise within the cross-functional...

  • Clinical Scientist

    Il y a 7 mois


    Gent, Belgique Argenx Temps plein

    For the expansion of our Clinical team, argenx is looking for a Clinical Scientist who directs the planning and implementation of clinical programs to meet corporate and clinical research goals. He/she will be the primary clinical/scientific contact for one or multiple clinical studies and provides clinical research expertise within the cross-functional...

  • Clinical Scientist

    il y a 1 mois


    Gent, Belgique Argenx Temps plein

    Job Description We are seeking a highly motivated Clinical Scientist to support our neuromuscular portfolio. He/she will be the primary scientific contact for a neuromuscular indication and clinical study. He/she will provides clinical research expertise within the cross-functional team, during the clinical development of the asset. This position is based...


  • Gent, Belgique Meet Recruitment Temps plein

    110000 EUR - 110000 EUR - Ghent, Belgium - Permanent **About**: Our client is a leading, innovative biotechnology company dedicated to developing cutting-edge antibody products to transform patients' with autoimmune disease lives. They are at the forefront of the immunology space, pioneering groundbreaking treatments for various diseases. Their mission is...


  • Gent, Belgique Argenx Temps plein

    This position reports into the Head Clinical Operations Excellence. We want to fill in the position in Europe or the United States. Roles & Responsibilities - Ensure oversight of the adequacy of processes in Global Clinical Operations. Ensure regulatory requirements and commitments are reflected in the procedural documents. - Identify and drive continuous...


  • Gent, Belgique Workplace Options Temps plein

    Founded in 1982, WPO is the largest independent provider of holistic wellbeing solutions. Through our customized programs, and comprehensive global network of credentialed providers and professionals, we support individuals to become healthier, happier and more productive both personally and professionally. Trusted by 51% of Fortune 500 companies, we deliver...


  • Gent, Belgique Workplace Options Temps plein

    Founded in 1982, WPO is the largest independent provider of holistic wellbeing solutions. Through our customized programs, and comprehensive global network of credentialed providers and professionals, we support individuals to become healthier, happier and more productive both personally and professionally. Trusted by 51% of Fortune 500 companies, we deliver...

  • Clinical Trial Lead

    Il y a 2 mois


    Gent, Belgique Argenx Temps plein

    The Global Clinical Trial Operations team is expanding and is looking for a Clinical Trial Lead. - The Clinical Trial Lead (CTL) is a cross-functional leader with global accountability for all operational deliverables of clinical studies from Final Protocol Concept Sheet to Clinical Study Report (CSR) and applicable results disclosure. The CTL provides...

  • Clinical Analyst

    Il y a 5 mois


    Gent, Belgique Agfa Temps plein

    Agfa HealthCare, is a division of the Agfa-Gevaert Group which is headquartered in Mortsel, Belgium and traded on Euronext Brussels (AGFB). At Agfa HealthCare, we support healthcare professionals across the globe to transform the delivery of care. Our focus is 100% on providing best-of-suite Imaging IT software solutions that enable secure, effective and...

  • Invoicing Administrator

    Il y a 6 mois


    Gent, Belgique Cerba Research Nederland Temps plein

    **As invoicing administrator within Cerba Research you pay a crucial role in ensuring the financial aspects of the business run smoothly. You will have overall responsibility for the billing process for specific clinical trials, including coordination with Project Management, Contract Management, Proposal Management and Controlling Department. You will be...

  • Clinical Trial Manager

    Il y a 2 mois


    Gent, Belgique Argenx Temps plein

    To support the expansion of our Global Clinical Trial Operations team, we are currently looking for a Clinical Trial Manager. - The Clinical Trial Manager (CTM) operates cross-functionally with global accountability for operational deliverables of clinical studies from Final Protocol Concept Sheet to Clinical Study Report (CSR) and applicable results...


  • Gent, Belgique MindCapture Temps plein

    CLINICAL TRIAL SUPPLY MANAGER - Biopharma- Ghent & remoteWHAT IS OFFERED We offer strong compensation packages that reward your abilities, hard work and ingenuity in achieving success. We reward you with competitive wages and offer a strong package with additional legal benefits such as meal vouchers, eco vouchers, high health insurance (DKV) and group...