Description de fonction

Quality Manager CTSU - CDI - 38h (h/f)

Détails de la société

The Clinical Trials Support Unit (CTSU) is a department of the Institut Jules Bordet. The Institut Jules Bordet is an integrated multi-disciplinary centre, unique in Belgium and with an international reputation. The hospital is an academic non-profit organisation devoted entirely to patients affected by cancer.

The whole CTSU team fight cancer through the design, set-up and conduct of innovative clinical studies that matters for patients.

With an experience of more than 20 years, we propose a wide range of services in clinical study management, from scientific support to operational activities. We promote an academic research while encouraging collaboration with other academic partners and pharmaceutical companies.

The CTSU is seeking a motivated and organized Quality Manager.

Fonction

Position

The Quality Manager works with the associate head of CTSU Operations to ensure that clinical trials processes are conducted in accordance with GCP, guidelines and external partner’s contracts in place.

Duties and Responsibilities:

  • Draft quality assurance policies and procedures in collaboration with the CTSU teams
  • Communicate quality standards, procedures and specifications (quality management system)
  • Draft CTSU Standard Operating Procedures (SOP) in close collaboration with CTSU teams
  • Ensure timely review and maintenance of CTSU SOP
  • Ensure CTSU activities are carried out according to the Standard Operating Procedures, and ICH GCP regulations, study protocols, and study specific manuals and procedures
  • Review essential study documents and organise training of study teams on these documents
  • Provide support to Operation Staff on the application of, and adherence to processes and day to day use of CTSU procedures, templates and guidelines
  • Maintain job descriptions, CVs and training records for CTSU employees up-to-date

Profil

Requirements:

Profile

  • Holds a degree in the field relevant to the proposed position
  • Knowledge of ICH-GCP and EU Directives applicable to Clinical Trials
  • Relevant experience (minimum 2 years) in quality management
  • Relevant experience in the Clinical Research field is an asset

Skills and competencies

  • English proficiency (written and oral), as well as French and/or Dutch
  • Advanced writing skills including ability to summarize information and to provide clear instructions to non-specialist audience
  • Advanced Microsoft Office skills (knowledge of Access ® is an asset)
  • Ability to work as a team member or independently with minimal supervision
  • Self-starter with strong problem-solving skills
  • Ability to prioritize multiple and varied tasks efficiently and accurately
  • Excellent interpersonal, verbal and written communication skills
  • Flexible attitude with respect to work assignments and new learning
  • Ability to handle confidential information

Offre

Offer:

  • Full time position
  • Long-term contract
  • Start date as soon as possible

For more information on the available position and environment, please follow the link https://ctsu.bordet.be

  • Montants annuels à temps plein : Echelle barémique (charte sociale): B 1/2/3

Min. : 27 513,39 € (index : 1.7410)

Max. : 48 555,63 € (index : 1.7410)

Le maximum est atteint après 27 ans d’ancienneté pécuniaire.

    • Montants annuels à temps plein : Echelle barémique (charte sociale) : A1 1/2/3

Min. : 37418,21 €

Max. : 59517,00 €

Le maximum est atteint après 23 ans d’ancienneté pécuniaire.

  • Publiée le:mar. 8 juin 2021
  • Lieu: Institut Jules Bordet
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