Clinical Trial Manager - Montrouge, France - DBV Technologies

DBV Technologies
DBV Technologies
Entreprise vérifiée
Montrouge, France

il y a 2 semaines

Sophie Dupont

Posté par:

Sophie Dupont

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Description

Missions:


Support Clinical Operations activities for assigned clinical studies including study planning (protocol designs), study start-up activities, protocol execution and study close-out as directed by and in collaboration with the Director Clinical Project Manager.

Ensure global clinical studies are managed according to Good Clinical Practice, local regulations, guidelines, and SOPs.


Activités prinicpales:

Ensure appropriate oversight and management of the CRO/service providers

  • Supervise service provider/CRO's country feasibility and site selection process in collaboration with Medical Affairs and Director clinical projects to identify and approve high quality investigators
  • Review and approve project plans developed by CRO/service providers (e.g., communication plans, risk management plans, project plans, safety management plans) in accordance with study objectives
  • Review status reports provided by CRO/service providers and highlight issues to facilitate decision making
  • Participate in meetings led by CRO/service providers, review minutes, and provide support to the Direct Supervisor so that CRO issues are proactively identified, communicated, and resolved in a timely manner
  • Oversee site payments to ensure timely payments by the CROs.
Work cross-functionally, using clinical operations expertise to ensure effective contributions, execution, and delivery of study activities

  • Ensure common understanding of activities across all stakeholders/line functions
  • Contribute to writing and updating of study documents such as: Protocol, Protocol amendments, Informed Consent Forms, Clinical Study Reports
  • Actively contribute, as needed to the preparation of clinical parts of IND/NDA/BLA/AMM/IMPD/DSUR dossiers


Conduct co-monitoring visits to ensure proper adherence to study protocols, develop/enhance site relations as needed which may include travel to a limited number of sites.


Compétences requises:


  • Good understanding of the drug development process and knowledge of Pharmaceutical Industry
  • Knowledge and experience of GCP/ICH practice, and the regulatory and ethical environment of Clinical Studies
  • Excellent organizational and management skills
  • Scientific rigor, ability to analyze, interpret, write and report
  • Good verbal and written communication skills
  • Good computer literacy

Formation Initiale:

Minimum of B.S degree or higher degree (M.S., MPH, M.D., Pharm D, PhD etc)


Expérience professionnelle:


  • Minimum 68 years of experience in a Clinical Operations role working on international/global Clinical studies within the Pharmaceutical/Biotechnology Industries or with a CRO
  • Experience in Pediatric Allergy, Asthma, Immunology, or Immunotherapy is a significant plus, but not mandatory. Pediatric experience in any therapeutic area is also a plus.
  • Experience/track record of having worked effectively in a multicultural environment Experience working in a matrix/crossfunctional corporate organizational

Nos valeurs fondamentales:


Chez DBV Technologies, nous célébrons la pleine expression de nos quatre valeurs fondamentales et des comportements professionnels qui leur sont associés.

Également connues sous le nom des « 4C's », ces valeurs (curiosité, courage, collaboration et crédibilité) sont profondément ancrées dans l'ADN de notre entreprise.


Courage:

Prendre des risques intelligents et s'entraider pour s'améliorer sans cesse. Repousser les limites, transformer les challenges en opportunités. Se responsabiliser sur nos choix, nos avis, nos actes.


Curiosité:

Continuer à explorer de nouveaux horizons. Se demander « Pourquoi ? » et surtout « Pourquoi pas ?


Collaboration:

Apprendre les uns des autres. Grandir et se développer en tant qu'équipe multiculturelle et internationale, au service de nos objectifs communs.


Crédibilité:

Donner le meilleur de nous-même. Notre transparence et notre savoir-faire sont la base de notre relation avec nos patients, nos partenaires, nos actionnaires. Les données et les résultats sont ce qui comptent le plus pour nous.
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