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Clinical Trials Director

2 months ago

Egham, Surrey, United Kingdom Essential Pharma Full time £80,000
Job Summary

We are seeking a highly experienced Clinical Trials Director to lead the overall management and oversight of clinical trials at Essential Pharma. As a key member of our team, you will be responsible for ensuring the successful execution of clinical studies, from planning and execution to regulatory compliance and site management.

Key Responsibilities
  • Study Planning and Execution
    • Develop detailed project plans, including timelines, budgets, and resource allocation.
    • Ensure all trial activities are conducted in compliance with GCP, FDA regulations, and other applicable regulatory requirements.
  • Regulatory Compliance
    • Manage the preparation and submission of regulatory documents, including INDs, IRBs, and ECs.
    • Ensure compliance with global regulatory requirements, including those in the US.
  • Site Management
    • Manage the preparation and submission of regulatory documents, including INDs, IRBs, and ECs.
    • Ensure compliance with global regulatory requirements, including those in the US.
  • Budget and Resource Management
    • Manage budgets and resources for clinical trials.
    • Ensure effective use of resources to meet project timelines and budgets.
  • Communication and Collaboration
    • Ensure regular updates to senior management on trial progress and milestones.
    • Prepare and present trial status reports.
Requirements
  • Education
    • Degree or equivalent in life sciences, medical science, or nursing.
  • Experience
    • Proven track record of managing clinical studies as a Clinical Trial Manager.
    • Global regulatory knowledge, including the US, and experience with biologics, oncology, and pediatrics.
  • Skills
    • Strong knowledge of GCP, ICH guidelines, and regulatory requirements.
What We Offer
  • Salary
    • Competitive salary, from £80,000.
  • Benefits
    • Agile working, with flexibility to work from home and in the office.
    • £150 towards home office expenses.
    • Healthcare insurance.
    • Pension scheme.
    • Life insurance.
    • Enhanced family leave.
    • Enhanced sick pay.
    • Annual leave, including bank holidays and shut-down periods.
    • Discretionary annual performance bonus.
    • Recognition program.