Vacatures
>
Gent

    Clinical Trial Manager - Ghent, België - Argenx

    Argenx
    Argenx Ghent, België

    3 weken geleden

    Default job background
    Voltijd
    Beschrijving

    As we are growing, we are currently looking for a Clinical Trial Manager (CTM).

    The CTM is responsible for all operational aspects of the assigned clinical studies from monitoring initiation till closure of the studies. The successful candidate will have clinical trial operational experience in phase I, II and III drug development phases and is an operational expert in the clinical trial activities from start-up, execution until closure and its underlying activities. The CTM will be the "operational clinical trial voice" for the assigned studies, both internally and externally, he or she is owning the timelines of a clinical trial project and is accountable to keep the trial on track. The successful candidate will excel in establishing good and effective internal and external working relationships.

    Reporting line

    The CTM reports to the Clinical Operations Development Lead (CODL)

    Roles & Responsibilities

    The CTM is responsible for all clinical operational aspects for the assigned global clinical trial(s) from preparation until closure. The trial responsibilities include:

  • Participate in the clinical trial team meetings, or, in case of a Lead CTM: lead the clinical trial team meetings together with the Lead Trial Physician
  • Oversee risk identification and mitigations for the clinical trials, provide solutions and oversee implementation
  • Oversee all trial related aspects, timelines, budget and quality. Close collaboration with the CODL on changes, issues and potential solutions
  • Ensure that clinical trials are executed according to the Clinical Development Plan (CDP), trial plans, OGSM and in compliance with argenx procedures, ICH-GCP and other applicable legislations
  • Support and participate in CRO and vendor selection
  • Lead CRO contracts negotiations together with the argenx vendor manager
  • Responsible for leading, guiding and overseeing the CROs and other (lab) vendors involved in the assigned clinical trial based upon metrics and plan
  • Member of the Country and Site Selection Commission for the specific trial
  • Provide input into and/or develop trial related materials such as clinical protocol, clinical monitoring plans, data management plan, eCRF and completion guidelines, patient information and informed consent, site instructions for specimen collections, patient retention and recruitment materials
  • Oversee and track patient recruitment and pro-actively identifies ways to prevent recruitment delays
  • Develop monitoring and site oversight strategy and oversee adherence to it. Perform site oversight visits according to plan
  • Review monitoring visit reports, protocol deviations and data listings to ensure reliable quality data are delivered and proactively identify and solve issues/concerns
  • Monitor data quality
  • Ensure that the Trial Master File (TMF) is maintained and up to date
  • Ensure timely availability of investigational product supply on site and ensure clinical site accountability records on site are in place and maintained
  • Ensure timely collection, documentation and reporting of Adverse events (AEs) and Serious AEs (SAEs) and collaborate in submission of the reports to FDA, EMEA and other applicable regulatory authorities
  • Ensure supportive relationships with clinical sites and trial personnel
  • Clearly communicate on goals/expectations and motivate team members, including vendors, to work towards achieving clinical trial goals
  • Pro-actively identify and solve issues in the assigned clinical trial and timely escalate them to CODL, Head of Trial Operations and/or Senior Management, as needed
  • Responsible and contact person during inspections/audits for the assigned trial together with the Quality Assurance representative
  • Identify efficiencies, best practices and lessons learnt. Search for and embrace innovation

    • The CTM will also participate in activities other than trial-related which include but are not limited to:

  • Provide input to the clinical development strategy/plan
  • Provide input to procedures/SOPs/WIs and related documents
  • Participate in workstreams
  • Ensure best practices and lessons learnt are shared across trials/indications/compounds

    • Skills & Competencies

  • Knowledge of ICH-GCP and other applicable legislation to successfully execute the clinical trial
  • Experience with tools and systems for managing clinical studies (MS project, trial progress and metric systems, eCRF databases)
  • Bachelor's degree or University degree – medical or para-medical (Biology, Biomedical Sciences, Pharmacy, Veterinary etc.) or equivalent by experience
  • Minimum of 5 years of experience in Clinical Operations and managing CROs and vendors
  • Biotech experience is a plus
  • Auto-immune and/or oncology clinical trial background is a plus
  • Proclinical

    Clinical Trial Manager

    2 weken geleden

    Proclinical Gent, België

    Proclinical is recruiting a Clinical Project Manager/Clinical Trial Manager for a Mid-size CRO. This role is on a permanent basis and is located in Belgium. · **Responsibilities**: · - Contribute to the strategy or plan for clinical development. · - In the allocated clinical stud ...

  • Meet Recruitment

    Clinical Trial Manager

    3 weken geleden

    Meet Recruitment Gent, België

    Clinical Trial Manager - Belgium - Pharma · - Leading global cross-functional project team delivery, accountable for achievement of milestones and quality of contracted scope · - Developing study management plans and ensuring consistent use of study tools, training materials and ...

  • MindCapture

    Clinical Trial Supply Manager

    3 weken geleden

    MindCapture Gent, België

    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 ben ...

  • Sillar Clinical

    Clinical Trial Manager

    1 week geleden

    Sillar Clinical Deurle, België

    Sillar Clinical is looking for an experienced Clinical Trial Manager (CTM). A CTM serves as the central contact and coordinating person within a specific trial. He/she coordinates the organization, implementation and management of clinical trials. CTM's role will interact with ot ...

  • Cerba Research Nederland

    Trial Set-up Qc Manager

    1 week geleden

    Cerba Research Nederland Gent, België

    As Trial Set-Up QC Manager you play a crucial role in ensuring that all aspects of the clinical trial are appropriately planned, documented, and executed to meet regulatory requirements and maintain data integrity. · The Trial Setup QC Manager performs the study set-up, Quality c ...

  • Argenx

    Clinical Trial Supply Sourcing Manager

    2 weken geleden

    Argenx Gent, België

    The Sourcing Manager IRT/Clinical Supplies Services is responsible for ensuring external vendor services are sourced and managed for argenx' development projects according to project needs, argenx standards and in accordance with applicable guidelines and regulations. · The role ...

  • Hôpital Erasme

    Erasme - Clinical Data Manager Clinical Trials

    2 dagen geleden

    Hôpital Erasme Anderlecht, België

    **Fonction**: · **Mission**: · Assurer et gérer les données récoltées au cours des études cliniques, en collaboration avec la Study Coordinatrice responsable. · **Tâches**: · - Vérifier que le traitement des données est réalisé en conformité avec les exigences réglementaires du C ...

  • Hôpital Universitaire de Bruxelles (HUB)

    Bordet - Clinical Data Manager Clinical Trials

    1 dag geleden

    Hôpital Universitaire de Bruxelles (HUB) Brussels, België

    **Société**: · L'Hôpital Universitaire de Bruxelles (H.U.B) regroupe l'Hôpital Erasme, l'Institut Jules Bordet et l'Hôpital Universitaire des Enfants Reine Fabiola (HUDERF). Créé en 2021 à l'initiative de la Ville de Bruxelles et de l'Université Libre de Bruxelles (ULB), ce grand ...

  • Cliniques universitaires Saint Luc

    Project Manager et CRA pour les études du programme KCE- TRIALS 2023

    2 weken geleden

    Cliniques universitaires Saint Luc Brussels, België CDI

    Les Cliniques universitaires Saint-Luc endossent la responsabilité de coordinateur national ou de promoteur dans le cadre de trois études multicentriques financées par le programme KCE-trials. · La mission du Project Manager et CRA pour les études du programme KCE- TRIALS 2023 s ...

  • Universitair Ziekenhuis Gent

    Project Manager Hiruz

    3 weken geleden

    Universitair Ziekenhuis Gent Gent, België

    **Datum**:5 jul. 2023 · **Plaats**: BE · **Bedrijf**:Universitair Ziekenhuis Gent · In het UZ Gent kom je terecht in een **innovatieve **omgeving die oog heeft voor je **talent **en je uitdaagt om te groeien. Dankzij het **engagement **van alle collega's voor patiënten, opleiding ...

  • MindCapture

    Franchise Clinical Operations Development Lead

    3 weken geleden

    MindCapture Gent, België

    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 consisten ...

  • Argenx

    Franchise Codl

    3 weken geleden

    Argenx Gent, België

    Franchise Clinical Operations Development Lead ( Franchise CODL) · PURPOSE OF THE FUNCTION · The Franchise CODL is responsible for the strategizing, planning, leading and execution of the operational path for all indications within a franchise from first in human studies through ...

  • Argenx

    Clinical Operations Development Lead

    2 weken geleden

    Argenx Gent, België

    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 Le ...

  • Argenx

    Clinical Data Manager

    2 weken geleden

    Argenx Gent, België

    For the expansion of our Clinical Data Management team, argenx is looking for a Clinical Data Manager (CDM). · Key Accountabilities/Responsibilities: · The CDM is responsible for all data management aspects of the assigned clinical studies from initiation till closure ensuring th ...

  • MindCapture

    Clinical Operations Development Lead

    3 weken geleden

    MindCapture Gent, België

    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 ...

  • Protealis

    Agronomist

    2 weken geleden

    Protealis Gent, België

    Protealis develops superior seeds and seed technologies for legume crops that are · adapted to our local North-European environment. By combining innovation in breeding · and nitrogen fixation we create new opportunities for European farmers to help · overcome Europe's protein de ...

  • Argenx

    Clinical Scientist

    2 weken geleden

    Argenx Gent, België

    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 ...

  • Argenx

    Senior Scientist Bioanalytical

    1 week geleden

    Argenx Gent, België

    For the expansion of our Bioanalytical team, argenx seeks a highly motivated Senior Scientist in Bioanalytics with specialized expertise in immunogenicity assay development/validation for large molecules and/or clinical immunogenicity risk assessment and data interpretation. · Th ...

  • Argenx

    Senior Scientist Bioanalytics

    1 week geleden

    Argenx Gent, België

    Operating under an outsourced model, argenx collaborates with bioanalytical vendors. The Senior Scientist will serve as the representative of the Bioanalytical team within one or multiple project teams, fostering close collaboration with internal and external stakeholders. · Resp ...

  • Viroclinics-DDL

    Scientific Liaison

    2 weken geleden

    Viroclinics-DDL Gent, België

    **PROFILE** · PhD / experienced PharmD or master/PhD in Life Sciences is preferred. · WHO WE ARE · Cerba Research provides the highest quality specialized laboratory and diagnostic solutions while leveraging patient data and scientific insight to shape and advance clinical trials ...