Project Manager Clinical

il y a 3 semaines

Paris e, France SMART IMMUNE Temps plein

**SMART IMMUNE RECRUTE UN(E) COORDINATEUR D’ETUDES CLINIQUES H/F EN CDI**

SMART IMMUNE est une société de biotechnologie au stade recherche clinique qui développe les thérapies cellulaires issues de progéniteurs de lymphocytes T à travers une plateforme innovante appelée ProTcell. Ces thérapies cellulaires, nouvelle génération, permettent en un temps record le « reset » d’un système immunitaire capable de lutter efficacement contre les cancers et les infections, améliorant significativement le pronostic et la qualité de vie des patients.

Afin d’accompagner notre croissance, nous recherchons un(e) coordinateur d’études cliniques.

**Missions**:
Rattaché au Chief Medical Officer (CMO), le/la Coordinateur d’études cliniques est responsable de l'exécution et de la coordination de toutes les activités requises pour la mise en place, le suivi et la clôture de ou des études cliniques qui lui sont confiées, dans le respect de la réglementation et des délais. Le/la Coordinateur d’études cliniques est l’interlocuteur privilégié de ou des études et assure la coordination avec toutes les parties prenantes (interne et externe tels que les prestataires, investigateurs) afin d'atteindre les objectifs des études dans un environnement hautement dynamique et complexe, dans le respect des intérêts de l’entreprise, des dispositions législatives et réglementaires en vigueur et conformément aux bonnes pratiques cliniques.

Il/elle aura pour missions, notamment de:
**Mettre en œuvre et suivre le plan d’études cliniques**
- Coordination des études cliniques menées en France, en Europe, et aux Etats-unis (de la faisabilité à la clôture)
- Mise en œuvre du protocole d’étude clinique (déroulement pratique des visites )
- Validation des cahiers d’observations
- Gestion opérationnelle des fournisseurs pour la réalisation des études cliniques
- Suivi du bon déroulement des études cliniques avec l’aide des ARC (recrutement des patients, contrôle de la qualité des études cliniques et du respect de la réglementation)
- Validation des comptes-rendus de monitoring
- Garant du suivi des événements indésirables en relation avec la pharmacovigilance

**Gérer les projets**
- Définition des besoins humains nécessaires à la réalisation des études cliniques (éventuellement)
- En charge de la gestion budgétaire, réglementaire et logistique des études cliniques (produits d’investigation cliniques, matériels, stocks)
- Animation et formation des ARC sur les spécificités d’une étude clinique
- Supervision de la réalisation des conventions hospitalières et des contrats investigateurs
- Participation aux réunions investigateurs

**Rédaction**
- Rédiger ou participer à la rédaction des protocoles cliniques, des amendements, des formulaires de consentement éclairé, des manuels d'étude et des plans d'étude, des formulaires de collection des données et de tout autre document lié à l’étude en collaboration avec les membres de l'étude.
- Préparer et gérer les soumissions aux comités d’éthique en collaboration avec les prestataires.

**Profil**

Formation souhaitée : Bac+5 en science

Expérience souhaitée : 5 ans d’expériences dans une société pharmaceutique (sponsor et/ou CRO).

Sont de plus
- Une expérience avec les documents réglementaires de l'UE et des États-Unis
- Une expérience des essais cliniques de phase I-II est requise
- Connaissance en oncologie et immunologie.

Anglais écrit et oral est essentiel

**Aptitudes & Compétences**
- Rigoureux dans l'utilisation et le référencement des données ;
- Flexibilité et sensibilité aux délais de livraison serrés et difficiles;
- Solides compétences organisationnelles et de gestion du temps;
- Capacité à gérer les priorités.

Type d'emploi : Temps plein, CDI
Statut : Cadre

Avantages:

- Titre-restaurant

Programmation:

- Du lundi au vendredi
- Travail en journée

Types de primes et de gratifications:

- Heures supplémentaires majorées

Formation:

- Bac +5 (Master / MBA) (Optionnel)

Expérience:

- production cellulaire classique: 5 ans (Optionnel)

Lieu du poste : En présentiel

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