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Ctms & etmf associate

Denmark, København Employment contract · Job Posted July 04, 2026
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Job Description

Do you enjoy bringing structure, quality, and clinical technology together? Are you motivated by helping study teams work efficiently and ensuring that clinical trial systems and documentation are compliant and inspection-ready? If you like solving system-related challenges and contributing to continuous improvement, this role could be a great match for you. At Sanos Integrated Solutions, we are looking for an experienced CTMS & eTMF Associate to join our Clinical Processes team for a 12-month maternity cover. You will become an important part of our Veeva ecosystem and support study teams across international clinical trials in a role with both operational responsibility and room to make a visible impact. The position is intended to cover responsibilities currently handled by our CTMS Manager, so we are looking for someone who is comfortable working hands-on with clinical trial systems and documentation management, particularly within Veeva CTMS and Veeva eTMF.

Job Responsibility

  • Maintain oversight of study setup, maintenance, and governance across Veeva CTMS and Veeva eTMF
  • Support study teams with system configuration, operational use, filing practices, metadata quality, and document lifecycle management
  • Perform data quality reviews, reconciliation activities, TMF completeness reviews, and health checks
  • Monitor system compliance, completeness, TMF quality metrics, and inspection readiness throughout the study lifecycle
  • Manage user access and user administration activities
  • Investigate and resolve CTMS and eTMF system-related issues in collaboration with IT, QA, study teams, and vendors
  • Lead testing, validation, and implementation of new Veeva functionality and enhancements
  • Assist with development and optimization of CTMS and eTMF-related processes
  • Contribute to SOPs, work instructions, guidance documents, and training programs
  • Maintain training materials, guidance documents, user support resources, and best practices aligned with regulatory requirements and the TMF Reference Model
  • Deliver training to Sanos staff, contractors, and study team members
  • Contribute to inspection-readiness and audit-preparation activities
  • Act as a key contributor to continuous improvement initiatives across Clinical Processes

Requirements

  • Degree in Life Sciences, Health Sciences, Information Science, Records Management, or a related field
  • Minimum 1–3 years of experience working with Veeva CTMS and/or Veeva eTMF
  • Experience working in clinical trials and GCP-regulated environments
  • Strong understanding of Trial Master File requirements and the TMF Reference Model
  • Experience with CTMS and eTMF administration, maintenance, and support
  • Experience training end users and supporting system adoption
  • Experience with User Acceptance Testing (UAT), validation, and system change management
  • Excellent written and verbal communication skills in English

What we offer

  • A 12-month maternity cover position in a growing clinical research organization
  • A key operational role with responsibility across Veeva CTMS and Veeva eTMF
  • Close collaboration with experienced clinical trial professionals across functions
  • Exposure to international clinical trials and inspection-readiness activities
  • The opportunity to contribute to process optimization, system improvements, and training initiatives
  • A supportive and collaborative culture where knowledge sharing and professional development are valued

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