Functieomschrijving

Data Manager - Clinical Trials Support Unit (CTSU) - COD - 38u (m/v)

Bedrijfsdetails

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 IJB CTSU is seeking motivated Data Managers.

Functie

Position

The Data Manager (DM) ensures that the right information is collected during a clinical trial and that data is accurate. This is achieved through careful design of the data collection tools, methodology for interrogating the data and close liaison with the other study management functions.

Duties and Responsibilities:

  • Develop the study database according to the protocol and the contract
  • Design the Case Report Form
  • Support the department development of documentation and process improvement:
  • Write or contribute to preparation of key plans, working instructions, guidelines for the department
  • Write or contribute to preparation of study protocol, informed consent forms and clinical research documents
  • File study documents in the trial master file
  • Provide input into Clinical Data Management System requirements, assuring protocol and/or contract requirements are met
  • Collect data generated during the study
  • Implement risk management strategies and contingency plans for clinical study deliverables
  • Share data management status and issues with the study team
  • Ensure studies are carried out according to the study protocol, SOPs, and ICH GCP regulations and study specific manuals and procedures
  • Prepare/clean data for analyses

The Data Manager reports to the Associate Head of CTSU Operations.

Profiel

Requirements:

Profile

  • Holds a degree in the biomedical, paramedical or scientific field
  • Knowledge of ICH-GCP and EU Directives applicable to Clinical Trials
  • Relevant experience in the Clinical Research field is an asset

Skills and competencies

  • English proficiency (written and oral)
  • Attention to detail and strong organizational skills
  • Ability to drive, manage and prioritize multiple and varied tasks efficiently and accurately
  • Ability to work as a team member or independently with minimal supervision
  • Self-starter with strong problem-solving skills
  • Effective at analysing problems considering the “big picture” and recommending appropriate corrective actions
  • Excellent interpersonal, verbal and written communication skills
  • Flexible attitude with respect to work assignments and new learning
  • Ability to handle confidential information

Aanbod

The position is offered full-time.


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

or www.bordet.be.

    • Jaarwedde voltijds: Loonschaal (sociaal charter): A1. 1/2/3

Min.: 37 418,21 €(index 1.7410)

Max.: 59 517,00 € (index 1.7410))

Het maximum wordt bereikt na 23 jaar geldelijke anciënniteit.

  • Online op:ma 13 september 2021
  • Locatie: Jules Bordet Instituut
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