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Pauwels Consulting | Multiple regions | Permanent, Independent, Full-time

Published on 25 days ago


Job description

Roles and responsibilities :

  • Self-management of Phase I to IV studies at a national and/or international level in accordance with BPC-ICH
  • Regulatory Submissions and follow-up with Authorities
  • Setting up of procedures and guidelines
  • Setting up and validation of Study documents, tracking and reporting tools
  • Writing up of Study documents: protocol, case report form, informed consent form, ...
  • Budget and Invoicing follow-up
  • Ensure respect of Study planning and specifications
  • Coordination of subcontractors (request for orders, specifications writing-up, negotiation, contract management)
  • Coordination with other departments: Regulatory Affairs, Biometry, Medical Experts, Pharmacovigilance, ...
  • Communication with Sponsors
    • Regular updates on Study status
    • Organization of regular meetings and teleconferences
    • Highlighthing on important information, major problems, suggest action plans, agreement with the Sponsor on action
  • Training and coaching of Project team
  • Determination and follow-up of the objectives of the team project
  • Setting-up and follow-up of project team objectives
  • Organization and animation of project meetings
  • Management of nonconformities and setting up of corrective action plans
  • Training of Junior CRA (presentations and co-monitoring visits on sites)
  • Answer to Request for Proposals
  • Participation to standard documents and procedures writing
  • Respect of quality commitments
  • Participating in the continual improvement of the Quality System
  • Identifying and to record non conformities


Required skills and qualities and expected level

  • Good level of English (spoken and written)
  • Knowledge of GCP and ICH Guidelines
  • Good command of office
  • Management skills
  • Organized
  • High sense of responsibilities
  • Ability to Synthesize
  • Pro-active, autonomous
  • Good interpersonal skills

Required level of education & experience
  • Bachelor in biomedical sciences or similar  with special training in Clinical research (DIUFARC, DIUFIEC or other)
  • At least 2 years of experience as CRA or CTC


Bezoek voor meer informatie over de vacature CPM of solliciteer online op de vacature CPM.

Luxembourg,Antwerp,Brussels,Flemish Brabant,Liège,Hainaut,Walloon Brabant,Western Flanders,Namur,Limburg,Eastern Flanders

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  • Academic Bachelor


  • Permanent
  • Independent
  • Full-time
  • Company car

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