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Clinical Study Manager Woluwe-Saint-Lambert Belgium,  

ASIT Biotech (company)


Posted on : 01 December 2016

Project Description

We are looking for a Clinical Study Manager 

Scope of the responsibility: 

In a metrical setting, the Study Manager will support the Project Manager and the Project Leader in all operational daily activities. 


Job description:


  • Operational  input  on  study  key  documents (protocol, CRF  and eCRF, diary  cards, monitoring  guidelines, data  management documents, tracking  log, coding  list  and  all other study related document) 
  • Support  the  preparation  of  all  the  key documents  required for  a  submission to  EC  or MOH 
  • Support  the  preparation  on and organization  of  Study  specific  training  such  as Monitors training or Investigators meeting /refreshers 
  • Organize the sites supplies with study material including IMPs 
  • Ensures and maintains adequate study medication supplies to the sites  
  • Set-up  and  maintain  eTMF  (define  key  documents  collection  according  to  study milestones) 
  • Contribute  in  study  team  meeting  (conducted with  CROs),  organize  the  meeting/TC details and take the minutes and action log  
  • Training  of  the  CRO  staff  on  the  product, the  indication  and  the  study  protocol,  to provide a scientific support to the CRO 
  • Perform remote monitoring to ensure study data is adequately recorded in eCRF and quality of the monitoring actives are as per defined  
  • Track and communicate to the study team on the overall study progress (for example patient enrolment rate, AE/SAE listings ) 
  • Support of department activities as required. 

Education and Skills 

  • Bachelor, Master in a scientific field  
  • Minimum  of  2 years previous  experience  in  pharmaceutical  industry,  preferably  as CRA 
  • Excellent knowledge of ICH-GCP 
  • Excellent capacity using IT office tools  
  • Master soft skills 
  • Fluency in English and French 
  • Excellent organizational and time management skills
  • Team spirit and teamwork ability 
  • Adaptability to a changing environment  
  • Presentation skills  
  • Past experience in immunotherapy for Allergy is an asset, enthusiasm is a must 


About Us

We are  a  Belgian  clinical  stage  biopharmaceutical  company  focused  on  the development  and  future  commercialisation  of  a  range  of  breakthrough  immunotherapy products for the treatment of allergies. We have a headcount of 22 staff members, located at our headquarters and in the laboratory.

Locations

Woluwe-Saint-Lambert, Brussels, Belgium

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