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Document Management Specialist (Non-Clinical Study & Biological Sample Operations) - Brussels

Octopus Computer Associates

Posted on Sep 21, 2022 by Octopus Computer Associates

Brussel, Belgium
IT
Immediate Start
Annual Salary
Contract/Project

Document Management Specialist (Non-Clinical Study & Biological Sample Operations) - Brussels - English speaking

One of our Blue Chip Clients is urgently looking for a Document Management Specialist (Non-Clinical Study & Biological Sample Operations).

Please find some details below:

Job Summary:

As the Document Management Specialist, you contribute to the effectiveness and efficiency of our team and the optimization of the quality of our Study Document Management and Biological Sample Operations business processes. You support our user community and contribute to the continuous improvement of our business processes.

Major Accountabilities:

  • Study Documentation Operational Management - Manage day-to-day operations of regulated and non-regulated documents, this includes:
    • Records/Workflow/Template management, Technical Support (QC formatting in accordance with the customer Writing Styles and publishing, and formatting standards for regulatory submissions), act as an ECMS (Electronic Content Management System) Business Administrator
  • Provide support and training to in scope users on e-content management systems and related business procedures and coordinate HBS requests and HBS orders according to users' needs
  • Develop/update business documentation
  • Quality Control:
    • Newly implemented and in routine processes to ensure compliance and consistency
    • In collaboration with the Biobank Delegate, ensure that the tools for the inventory, tracking and storage of HBS comply with the operational standards for the acquisition, use, destruction, transfer, and storage of HBS
  • Coordinate Business Process Improvement (BPI) initiatives in order to streamline, simplify, standardize e-content management and Human Biological Samples (HBS) Biobank processes
  • Reporting: run and evaluate data reports, provide metrics and KPI's for both study document management and HBS Biobank activities

Education/Qualification:

  • Experience of working in pharma industry, knowledge of pharmaceutical development processes, conduct of non-clinical studies and scientific deliverables
  • Scientific background
  • Proven experience under GxP (GLP, GCP) regulations
  • Proven experience in database management, ECMS (Electronic Content Management Systems, eg Veeva Vault)
  • Experience with HBS biobanking database is an asset
  • Experience in project coordination/management, any project management certificate is an asset

Competencies:

  • Excellent planning and organizational skills
  • Excellent technical skills, extensive computer skills
  • Very good communication skills
  • Priority management, ability to work on multiple objectives
  • Analytical, sequential and process compliance minded, attention to detail
  • Service management, demonstrate creative problem-solving skills to find effective solutions
  • Customer and quality focused
  • Ability to work alone but also as an integral member of the team

Please send CV for full details and immediate interviews. We are a preferred supplier to the client.

Reference: 1736304352

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