Clinical Scientist (H/F)

Résumé du poste
CDI
Gif-sur-Yvette
Salaire : Non spécifié
Télétravail non autorisé
Expérience : > 2 ans
Éducation : > Bac +5 / Doctorat
Compétences & expertises
r
amp
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Le poste

Descriptif du poste

 

The Clinical Scientist is a key member of the Innovation Life Cycle Management team with responsibilities to provide scientific support for late-stage clinical studies. The role requires close collaboration with Asset Leaders, Medical Advisors alongside other R&D Departments responsible for project management, clinical operations and data management. The Clinical Scientist will have a key role in scientific external relationships with key opinion leaders and provide clinical input on safety and regulatory interactions. A working knowledge of late-stage drug development process, Good Clinical Practices (GCP), ICH guidelines is highly desirable.

 

Responsibilities :

 

  • Acts as the Clinical referent for study team, investigators, authorities, business partners and experts 
  • Designs clinical study synopsis, protocols, consent forms and amendments 
  • Analyze clinical data provided by statisticians (clin and RWE) from clinical database and provide sound clinical and technical advice during clinical study testing phase, including input during clinical study risk management
  •  To participate to Investigators, Monitors meetings on request  
  • Prepare summary clinical study findings and presentations 
  • Assigned to late-stage clinical feasibility project and S-project Core Teams (study Team) and participate to elaboration of development plan and proposed clinical plan.
  • S-project documentation, prepare relevant expert sections (e.g. Investigator brochure, Briefing book, Scientific advice and safety reports
  • To help identify clinical experts as require on assigned projects 
     

Profil recherché

Description du profil :

  • PhD, PharmD, MD or master’s degree in related discipline
  • Microsoft Office, & analyses 
  • Working knowledge of guidelines and GCP
  • 2-3 years of experience in late-sate clinical development of drugs with preferred experience in the field of cardiovascular and metabolic diseases or Single Pill Combination Development
  • Excellent interpersonal skills with stakeholders internally and externally
  • Able to work in English and with international partners
  • Self-motivated and able to work with limited supervision
  • Team working essential 

 

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