Clinical Trial Manager

**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
- Over-see 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 6-8 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 multi-cultural environment Experience working in a matrix/cross-functional 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.