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Clinical Trial Manager

Sejelas

Clinical Trial Manager

We are seeking to recruit an experienced Clinical Trial Manager for a biotechnology company developing novel therapies for genetic cardiomyopathies. Location: Europe/ United States (remote) Reports to: Head of Clinical Operations

Some of the responsibilities include:

  • Manage the day-to-day planning, execution, and delivery of early-phase (Phase I and II) clinical trials in compliance with ICH-GCP guidelines and SOPs.
  • Oversee trial timelines and budgets to ensure studies are completed on schedule and within financial parameters.
  • Assessing risks and implement mitigation plans during the trial
  • Manage site feasibility, selection, initiation, monitoring, and close-out activities for global studies.
  • Collaborate with cross-functional teams to ensure trial priorities are clearly communicated and executed.
  • Support the development and refinement of departmental SOPs, guidelines, procedures, and

Qualifications

  • Bachelor's degree (or equivalent) required.
  • 5+ years of relevant experience, at least 3 years of study management experience in a biotech.
  • Hands-on experience managing clinical trials in the EU and/or US.
  • Prior experience in managing FIH gene therapy trials is required.
  • Excellent communication, project management, and organization skills.
  • Flexibility and ability to prioritize and manage multiple tasks in a challenging environment.
  • Excellent written and oral communication skills; fluency in English as a business language.
  • Ability to travel (up to 25% time) internationally
Vacancy posted 3 days ago
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