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Regulatory Submission (Study Start-Up) Manager

  • Location

    London, England

  • Sector:

    Regulatory Affairs

  • Job type:

    Permanent

  • Salary:

    Negotiable

  • Contact:

    Matt Thomas

  • Contact email:

    matt.thomas@pharma-partners.co.uk

  • Job ref:

    28137_1650961228

  • Published:

    27 days ago

  • Consultant:

    Matt Thomas

Job title: Regulatory Submission (Study Start-Up) Manager

A global CRO with offices in Central London are seeking a Regulatory Submissions Manager to join their Clinical Operations team. This is an office-based role with flexibility to work from home 2 days per week.

Responsibilities:

  • Efficiently manage and successfully execute all aspects of global start-up
  • Perform quality checks on submission documents and site essential documents
  • Prepare and approve informed consent forms
  • Review pertinent regulations to develop proactive solutions to start-up issues and challenges; and
  • Present during bid defenses, general capabilities meetings, and audits.

Requirements:

  • Extensive experience in clinical research, preferably with a CRO. Experience may include CRA or project management experience
  • Knowledge and experience of Clinical Trial Applications within Europe
  • Strong oral and written communication skills; and
  • Team oriented approach and strong leadership skills.

Salary and benefits:

A competitive annual salary and benefits package is on offer with this role.

To apply for this position or hear further details then please contact Matt Thomas via matt.thomas@pharma-partners.co.uk