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Centralized Clinical Team Lead II (Ukraine)

Fortrea · Kiev

Senior 🇬🇧 English
Trip Report review ETMF reconciliation Document review

Job description

About the role

The Centralized Clinical Team Lead II (CCTL‑II) will oversee complex clinical projects, ensuring monitoring activities comply with Fortrea SOPs, ICH GCP guidelines and regulatory standards. The role acts as a key liaison between Clinical Research Associates, project managers and global teams to drive study delivery and patient safety.

Key responsibilities

  • Manage complex projects under the direction of a Project Manager/Director.
  • Ensure site monitoring follows Fortrea SOPs, ICH Guidelines and GCP.
  • Review Trip Reports, develop best‑practice templates and support project plans.
  • Identify and lead process‑improvement initiatives, implementing revised procedures.
  • Escalate project issues, corrective actions and clinical operations risks.
  • Communicate trends, safety concerns and outstanding issues to the study team.
  • Mentor and train new CCTLs on Trip Report review processes and quality checks.
  • Support study teams during CQC visits and assist with document review, ETMF reconciliation and slide‑deck creation.

Required profile

  • University/College degree in Life Sciences or allied health (or equivalent experience).
  • 10+ years of clinical research experience with strong knowledge of ICH‑GCP.
  • Minimum 2 years of Trip Report review experience.
  • Proven ability to manage risks, drive improvements and mentor junior staff.

Required skills

  • ICH GCP guidelines
  • Trip Report review
  • ETMF reconciliation
  • Document review and SOP compliance

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Published 1 month ago

Expires 3 days from now

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Fortrea

Kiev