European Clinical Study Start-Up Specialist – Hybrid

Oxford Global Resources

Diegem

Hybrid

EUR 60,000 - 90,000

Full time

14 days+
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Benefits offered by this job

Fulltime position
Hybrid working
Salary based on experience

Job summary

Oxford Global Resources is seeking a Clinical Study Start-up Specialist for a medical device client in the Brussels area. The role covers Belgium and the Netherlands, requires fluent Dutch and English, and 5–6 years in clinical research with EC submissions.

Hybrid work 2–3 days in the office, with global stakeholders and cross-functional collaboration. The successful candidate will independently manage regulatory docs, study activation, and risk mitigation, contributing to on-time delivery of

Qualifications

  • Fluent Dutch and English.
  • 5–6 years in clinical research or related environments.
  • Experience with Ethics Committee submissions.

Responsibilities

  • Lead Ethics Committee submission and site activation activities in Belgium and the Netherlands.
  • Manage submission strategies, timelines, risks and stakeholder expectations.
  • Handle regulatory documentation ensuring quality, compliance and inspection readiness.
  • Maintain study information in Veeva Vault, CTMS, eTMF and other systems.
  • Partner with Clinical Operations, Site Management, Trial Management and other stakeholders.
  • Identify risks early and drive mitigation strategies with limited supervision.
  • Support audit and inspection readiness activities.
  • Share knowledge and mentor team members as appropriate.
  • Contribute to process improvements to enhance efficiency and compliance.

Skills

Dutch language
English language
Clinical research
Ethics Committee submissions
GCP knowledge
Independent work
Cross-functional collaboration
Regulatory submissions

Tools

Veeva Vault
CTMS
eTMF

Job description

Oxford Global Resources is seeking a Clinical Study Start-up Specialist for a medical device client in the Brussels area. The role covers Belgium and the Netherlands, requires fluent Dutch and English, and 5–6 years in clinical research with EC submissions.

Hybrid work 2–3 days in the office, with global stakeholders and cross-functional collaboration. The successful candidate will independently manage regulatory docs, study activation, and risk mitigation, contributing to on-time delivery of

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