Senior Clinical Trial Associate

TFS HealthScience

Copenhagen, Denmark
On-site
Ich gcp compliance
Ctms management
Trial master file management
TFS HealthScience is seeking a Senior Clinical Trial Associate in Copenhagen, Denmark, to support clinical trial operations, ensuring compliance with ICH GCP and regulatory requirements. The role involves coordinating study documentation and supporting various phases of clinical trials, particularly within cardiology

Job Summary

  • The Senior Clinical Trial Associate is responsible for coordinating and maintaining study documentation and supporting clinical trial operations to ensure compliance with ICH GCP, SOPs, and regulatory requirements.
  • As part of our SRS FSP team, you will be dedicated to one sponsor and support the execution of a Phase 2 clinical study within cardiology.
  • We provide opportunities for personal and professional growth in a rewarding environment.

Matching Summary

Match Score: 85

TFS HealthScience is seeking a Senior Clinical Trial Associate in Copenhagen, Denmark, to support clinical trial operations, ensuring compliance with ICH GCP and regulatory requirements. The role involves coordinating study documentation and supporting various phases of clinical trials, particularly within cardiology.

Skills & Requirements

Must-have

  • ICH GCP compliance
  • CTMS management
  • Trial Master File management
  • study documentation
  • regulatory submissions support

Nice-to-have

  • process improvements
  • mentoring junior team members
  • collaboration
  • quality focus

Key Requirements

  • Minimum 3 years of experience as a Clinical Trial Associate
  • Bachelor’s degree in life sciences or related field preferred
  • Strong knowledge of ICH GCP
  • Experience with CTMS and Trial Master File management
  • Experience supporting regulatory submissions

Work Rights

Not specified

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