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National Clinical Trial Manager (M/F)

September 1st 2020

The Belgian Society of Paediatric Haematology and Oncology (BSPHO) was founded in 1996 as a collaboration between professionals of the recognized Belgian centers in paediatric haemato-oncology to share expertise and knowledge to improve treatment of childhood cancer and patient care. The number of children and adolescents with cancer is relatively small so participation in large (mostly academic) clinical trials is essential to gather enough data to draw meaningful conclusions regarding better treatment options. Many children and young adults with cancer are treated in large clinical trials since several decades. This has contributed to the better cure rates for children with cancer in general. The national coordination team of the BSPHO coordinates the set-up and follow-up in Belgium of international academic studies that are chosen collaboratively by the Belgian PHO centers.

Mission Description

  • Start-up and implementation of international academic trials in close collaboration with the national investigator linked to one of the 8 Belgian Pediatric Hemato-Oncology (PHO) centers.
  • Based on the protocol, definition of the study requirements and corresponding costs in order to establish the budget.
  • Prepare and submit project funding/grant applications.
  • Review and follow-up of contracts with the international sponsor and participating centers in Belgium (incl. ensuring regular invoicing to/by BSPHO).
  • Preparation and submission of regulatory documents to the Ethics committee and competent authorities.
  • Informed Consent Form (ICF) adaptation and translation (Eng=>Fr/Nl).
  • Preparation of national site initiation, provision of documents for the investigator site file and leading of initiation visits of participating sites.
  • Support participating centers in case of any study-related questions.
  • Review and submission of amendments to Ethics committee and competent authorities and study close out visit.
  • Organization/participation/reports writing of BSPHO meetings (working groups, scientific meetings, annual clinical trial day, BSPHO symposium, … ).
     

Candidate profile

  • Master degree, ideally in life sciences or biomedical sciences ;
  • Previous experience in clinical trials required ;
  • Knowledge of GCPs (Good clinical Practices) ;
  • Competences in project management (communication, negotiation, problem solving, budgets, …) ;
  • Fluent in French and English, Dutch is an asset ;
  • Working knowledge of MS office ;
  • Strong communication skills, well-organised, able to work independently and in team, detailed oriented ;
     

Offer

  • Full-time (or 80%) permanent contract
  • Work-life balance and flexible working condition
  • Attractive salary package including extra-legal advantages
  • Job location :  30, Clos Chapelle-aux-Champs.  1200 Brussels

Contact Details

Send your CV and motivation letter to pierre.mayeur@bspho.be (please include the ref NC-2020-09 in the subject line of your email)