Clinical Project Manager

4 days ago


Egham, Surrey, United Kingdom Essential Pharma Full time

Job Title: Clinical Project Manager

Job Summary:

Essential Pharma is seeking a highly skilled Clinical Project Manager to lead the overall management and oversight of clinical trials. As a key member of our team, you will be responsible for ensuring the successful execution of clinical studies, from planning to completion.

Key Responsibilities:

  • Study Planning and Execution: Develop detailed project plans, including timelines, budgets, and resource allocation, to ensure the successful execution of clinical trials.
  • Regulatory Compliance: Ensure all trials are conducted in compliance with Good Clinical Practice (GCP), FDA regulations, and other applicable regulatory requirements.
  • Regulatory Document Management: Manage the preparation and submission of regulatory documents, including Investigational New Drug (IND) applications, Institutional Review Board (IRB) approvals, and Ethics Committee (EC) approvals.
  • Site Management: Manage the preparation and submission of regulatory documents, including Investigational New Drug (IND) applications, Institutional Review Board (IRB) approvals, and Ethics Committee (EC) approvals.
  • Budget and Resource Management: Manage budgets, resources, and risks associated with clinical trials.

Requirements:

  • Education: Degree or equivalent in life sciences, medical science, or nursing.
  • Experience: Clinical trial management experience gained in a Clinical Trial Manager role with a proven track record of managing clinical studies.
  • Regulatory Knowledge: Global regulatory knowledge, including the US, and experience of biologics, oncology, and pediatrics would be highly desirable.
  • Skills: Strong knowledge of GCP, ICH guidelines, and regulatory requirements.

What We Offer:

  • Salary: From £80,000.
  • Agile Working: We offer flexibility and trust from day one, with the option to work from home or in our office.
  • Benefits: £150 towards your home office, healthcare insurance, pension, life insurance, enhanced family leave, enhanced sick pay, annual leave, discretionary annual performance bonus, and recognition program.


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