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« Senior Clinical Research Associate » (M/F)

Promethera Biosciences is a Belgian biotech company developing innovative therapies for the treatment of liver diseases. Its proprietary cell-based technology platform is based on allogenic progenitor cells isolated from healthy adult human liver donors (Heterologous Human Adult Liver-derived Progenitor Cells, HHALPC). Today, Promethera Biosciences has successfully completed a first Phase I/II clinical trial in orphan liver diseases (UCD, CN, Urea Cycle Disorders; Crigler Najjar) and has launched a Phase II study in UCD. The company is building a strong preclinical program on large liver indications and is continuing the development of its technological platforms: HepaStem and the follow-on product H2Stem.

If you are sharing our vision of developing innovative advanced therapies for inborn and acquired liver diseases and if you are looking for “from bench to bedside” development challenges amongst a dynamic team, consider collaboration with our fast growing company. Promethera Biosciences is currently hiring a Clinical Trial Assistant to support the Clinical Department in handling new trials.

 

MAIN RESPONSIBILITIES

The selected candidate will:

 

  • In collaboration with the Head of Clinical Development and the medical/clinical team, prepare and manage clinical trials with HepaStem (protocols, ICF, IDB, CRF’s, study files, etc.)
  • Develop and write SOPs for the Clinical Research Department related to Clinical trials
  • Prepare and start-up the clinical sites in due course, perform clinical monitoring when needed
  • Train Promethera’s staff and clinical trial sites to clinical trial requirements
  • Collaborate closely with the R&D and regulatory teams to fulfill the clinical trial requirements
  • Engage and ensure coordination/project management with external resources (CRO’s)
  • In collaboration with the Head of Clinical Development, organize and work-out advisory boards, investigators’meetings, seminars at congresses

 

QUALIFICATIONS

  • Educational background in disciplines of science, biomedical science or medicine/health care (MSc, PhD, MD)
  • Prior experience in clinical monitoring (full process of a CT implementation: from protocol design until completion of trial and reporting of results)
  • Excellent skills in literature reviews and eager to learn about new therapeutic area’s
  • Excellent English writing skills
  • Good English and French verbal communication skills 
  • Good Computer Skills (project management)
  • Excellent organizational and communication skills (interaction with physicians and study site staff)
  • Flexibility to operate in multitasks environment
  • Experience in Advanced Therapy Medicinal Products and Orphan Drugs would be an advantage

 

You may apply for this position by sending your CV and application letter to contact@promethera.com