Clinical Project Support Specialist

hace 1 día

Barcelona, Barcelona, España Mygwork A tiempo completo

Job Summary:

The Clinical Project Support Specialist will provide comprehensive operational support to the global study team, ensuring the smooth execution of phase I-IV clinical trials. This role is pivotal in offering administrative, logistical, and operational support on a global level.

Key Responsibilities:

  • Administration & Logistics:
    • Create and maintain different study documents and tools to support all different roles of the study.
    • Update study Q&A and Action log.
    • Set-up and maintain different project and study platforms/software.
    • Support audits and inspections according to company policy and SOPs.
  • Meeting Support & Communication:
    • Act as a Study Team key contact with eTMF Specialist/System Specialist.
    • Support to set up and manage Clinical/Study Team and Steering Committee meetings.
  • Operating Trackers/Reports:
    • Maintain different study trackers to keep study information up to date and ensure study oversight/quality at different study levels.
  • System Management:
    • Upload/file/review different study level documents in eTMF and provide updates/reports on eTMF status.
  • Vendor/CRO Handling:
    • Support outsourced studies, maintain oversight of CRO eTMF, Veeva by ongoing QC in the systems if needed.

Qualifications and Requirements:

The clinical development study and project coordination activities are accomplished through a strong skillset, understanding of clinical development and global operating processes of drug development as well as in-depth knowledge of ICH-GCP and international regulations.

Requirements:

  • Bachelor's degree or equivalent in a relevant field.
  • 1+ year of experience in clinical research/development ideally in the pharmaceutical industry.
  • Candidate ideally brings experience working with VEEVA System.

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