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