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Clinical Trial Manager III

Fortrea · Taipei

New Remote
Remote 🇬🇧 English
Microsoft Office EDC CTMS eTMF Veeva Vault Medidata

Job description

About the role

The Clinical Trial Manager III owns the clinical delivery and operational oversight of research trials within the core project team. The role collaborates with project managers and functional leads to deliver start‑up and clinical activities on time, within budget, and in compliance with regulatory and client requirements.

Key responsibilities

  • End‑to‑end oversight of trial start‑up through database lock, managing scope, timelines, milestones and budget.
  • Develop and execute site activation and recruitment strategies, including site identification, selection and contract negotiations.
  • Lead regulatory and ethics committee submissions, approvals and tracking.
  • Oversee informed consent form development, translations, essential document collection and insurance.
  • Manage clinical and ancillary supplies, import/export logistics and supply destruction.
  • Plan and supervise monitoring activities to ensure data integrity, patient safety and endpoint protection.
  • Ensure inspection readiness through quality oversight of TMF, monitoring reports and protocol deviations.
  • Track financial aspects, revenue forecasting, scope modifications and site payments.

Required profile

  • University degree in life sciences or related health profession (or equivalent experience).
  • Five or more years of clinical research experience in pharma, CRO or healthcare settings.
  • Comprehensive knowledge of GCP, ICH and regulatory guidelines.

Required skills

  • Proficiency in Microsoft Office.
  • Experience with electronic data capture (EDC) systems.
  • Familiarity with Clinical Trial Management Systems (CTMS).
  • Knowledge of electronic trial master file (eTMF) platforms.
  • Use of Veeva Vault and Medidata platforms.

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Published 7小时前

Expires 1个月后

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Fortrea

Taipei