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Study Operations Specialist

hace 2 meses

Madrid, Madrid, España Engineeringuk A tiempo completo
Job Title: Study Operations Specialist

As a Study Operations Specialist at Engineeringuk, you will play a pivotal role in the success of our clinical trials.

Key Responsibilities:

  • Lead and support operational activities from start-up to close-out for assigned studies.
  • Ensure compliance with study timelines, prevailing laws, Good Clinical Practices, and client standards.
  • Register investigator sites and client stakeholders in client registries and systems.
  • Collaborate with investigator sites to confirm readiness for site start-up.
  • Resolve issues and escalate site issues as needed.
  • Prepare and submit regulatory documents.
  • Manage and coordinate with other supporting roles to ensure timely site activation.

Requirements:

  • Bachelor's degree in life sciences or equivalent experience.
  • Minimum 2 years of experience in clinical site management.
  • Knowledge of clinical trial methodologies, ICH/GCP, FDA, and global/local country regulations.
  • Fluency in English and local language.
  • Effective communication and technical skills.