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Senior Clinical Research Associate (Level I)

Thermo Fisher Scientific

Senior 🇬🇧 English
CTMS

Job description

About the role

Thermo Fisher Scientific is seeking a Senior Clinical Research Associate (Level I) to support the delivery of global clinical trials. In this position you will act as a key liaison between investigational sites, sponsors and internal project teams, ensuring that studies are conducted according to protocol, regulatory standards and company procedures.

Key responsibilities

  • Plan and execute remote and on‑site monitoring visits using a risk‑based approach.
  • Perform source data review, source data verification and case report form checks to guarantee data quality.
  • Verify investigational product accountability and manage inventory records.
  • Identify site deficiencies, document findings and drive corrective and preventive actions.
  • Maintain regular communication with sites to support protocol compliance and timely data entry.
  • Ensure study documentation meets regulatory requirements and support audit/inspection readiness.
  • Provide status updates to the Clinical Team Manager and keep study systems, including the Clinical Trial Management System, up to date.

Required profile

  • Minimum 3‑5 years of experience in clinical monitoring for pharmaceutical or biotechnology studies.
  • Strong knowledge of ICH‑GCP, applicable regulations and standard operating procedures.
  • Excellent analytical and problem‑solving abilities with a focus on data integrity.
  • Effective communication skills for interaction with investigators and cross‑functional teams.

Required skills

  • Proficiency with Clinical Trial Management Systems (CTMS).

Questions fréquentes

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Published 1 month ago

Expires 3 weeks from now

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Thermo Fisher Scientific