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Experienced Clinical Data Manager (EU)

  • Lieu:

    Herzele

  • Contact:

    Aurelie Petit

  • Type de poste:

    Contract

  • Téléphone de contact:

    +32 10 68 53 32

  • Secteurs d’activité:

    Life Sciences, Clinical Research

  • Contact E-mail:

    aurelie_petit@oxfordcorp.com

Do you have Clinical Data Management experience and would like to be part of a dream team in a growing and exciting Medical Devices company? Apply now!

Job Description

The Clinical Data Manager (CDM) leads end to end data management activities on diverse scope projects.

Responsibilities

  • Collaborate with Clinical Monitors, Clinical Study Managers, Clinical Research Associates and Biostatisticians to ensure all data is complete, timely, and accurate.
  • Enter data from research studies into the proper Clinical Data Management Systems.
  • Review data for quality and resolve discrepancies.
  • Assist in development, maintenance and management of case report forms/study worksheets to ensure consistency with the protocol and database.
  • Assist in development of the Study Requirements Specification (SRS).
  • Contribute to study-specific data management processes including Data Management Plans, User Guides, Case Report Form Completion Guidelines, and other study documentation.
  • Generate data output and coordinate data output documentation.
  • Perform database validation under the guidance of the Clinical Database Developer or Data Management department leadership.
  • Contribute to the review and creation of processes related to Data Management.
  • Perform project in compliance with regulations.
  • Support routine internal audits of projects.
  • Ensure that the product/deliverable is the best it can be given time and budget constraints.
  • Function at a level that affords respect by internal NAMSA Associates/team members.
  • Communicate project/team issues to Project Manager and/or Management.
  • Function as a productive project team member.
  • Keep project plan or study calendar updated.
  • Contribute to presentations, including preparation, assembling slides, and speaking.
  • Network with peers in the medical device industry.
  • Inform manager or marketing colleagues of potential opportunities.

Requirements

  • Bachelor's degree or equivalent experience in a related field, with a minimum of 3-5 years of relevant experience.
  • Fluency in English and local language, if different, required.

Technical Competencies:

  • Familiar with clinical trial processes such as site selection/qualification, site initiation, monitoring, close-out.
  • Ability to effectively communicate with physicians, health care workers, study coordinators, IRB/EC/REB personnel.
  • Technically conversant with respect to Clinical Data Management Systems.
  • Existing right to work in Europe required

Benefits

  • Fulltime position in full remote
  • Open for employee and freelance profiles
  • A balanced salary package based on your capabilities and experience

Vacancy number: 20920