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Clinical Trial Coordinator

msd · DNK - Hovedstaden - Copenhagen

New
Onsite 🇬🇧 English
Clinical Data Management Clinical Development Clinical Documentation Clinical Research Clinical Trial Compliance Clinical Trial Documentation Clinical Trial Management Clinical Trials Monitoring Clinical Trials Operations Clinical Trial Support Good Clinical Practice (GCP) ICH GCP Guidelines On Site Monitoring Research Designs Site Initiation Status Reporting Study Design Task Management

Job description

About the role

The Clinical Trial Coordinator (CTC) will be the operational heartbeat of multi‑country clinical studies, ensuring sites are ready, documents are inspection‑ready, and trial milestones are met.

Key responsibilities

  • Drive trial and site administration and coordinate site readiness with internal and external stakeholders.
  • Manage logistics for clinical and non‑clinical supplies, labeling, and translations.
  • Track essential documents and safety updates to maintain data integrity.
  • Operate Clinical Trial Management Systems (CTMS), electronic Trial Master Files (eTMF) and related clinical systems.
  • Prepare, archive and reconcile eTMF content for inspection readiness and execute quality control plans.
  • Support IRB/IEC and regulatory submissions, track insurance certificates and ensure publication of study results per local legislation.
  • Assist with budgets, contracts, payments and ensure compliance with financial procedures.

Required profile

  • Bachelor’s degree preferred in life sciences, health, office management, administration, finance or related field.
  • Experience in a clinical research environment with solid understanding of drug development and ICH‑GCP.
  • Fluent in English and Danish with proven ability to work independently and in multicultural, global teams.
  • Strong analytical mindset, attention to detail and ability to prioritize and deliver on time.

Required skills

  • Clinical Data Management
  • Clinical Development
  • Clinical Documentation
  • Clinical Research
  • Clinical Trial Compliance
  • Clinical Trial Documentation
  • Clinical Trial Management
  • Clinical Trials Monitoring
  • Clinical Trials Operations
  • Clinical Trial Support
  • Good Clinical Practice (GCP)
  • ICH GCP Guidelines
  • On Site Monitoring
  • Research Designs
  • Site Initiation
  • Status Reporting
  • Study Design
  • Task Management

Questions fréquentes

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Source : ats:workday

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Published for 1 dag siden

Expires om 1 måned

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msd

DNK - Hovedstaden - Copenhagen