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Senior Clinical Research Manager

2 months ago

Egham, Surrey, United Kingdom Essential Pharma Full time
Job Summary

We are seeking a highly skilled Clinical Trial Manager 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 trials, from study planning and execution to regulatory compliance and vendor 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 Good Clinical Practice (GCP) and relevant regulatory requirements.
  • Regulatory Compliance
    • Manage the preparation and submission of regulatory documents, including Investigational New Drug (IND) applications, Institutional Review Board (IRB) approvals, and Ethics Committee (EC) approvals.
    • Ensure all trial-related documentation is accurate, complete, and compliant with regulatory requirements.
  • Vendor Management
    • Manage relationships with vendors, including contract research organizations (CROs), clinical research sites, and other external partners.
    • Ensure vendors meet regulatory requirements and adhere to company standards.
  • Team Management
    • Mentor and manage a team of clinical trial professionals.
    • Provide guidance and support to ensure team members meet their responsibilities and deliver high-quality results.
  • Communication and Collaboration
    • Ensure regular updates to senior management on trial progress and milestones.
    • Prepare and present trial status reports to stakeholders.
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.
    • Global regulatory knowledge, including the US, and experience with biologics, oncology, and pediatrics would be highly desirable.
  • Skills
    • Strong knowledge of GCP, ICH guidelines, and regulatory requirements.
    • Excellent communication, leadership, and project management skills.
What We Offer
  • Competitive Salary
    • Salary range: £80,000.
  • Agile Working
    • Flexible working arrangements, including remote work options.
  • Benefits
    • Healthcare insurance.
    • Pension scheme.
    • Life insurance.
    • Enhanced family leave.
    • Enhanced sick pay.
    • Annual leave: 26 days plus bank holidays.
    • Discretionary annual performance bonus.
    • Recognition program.