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Clinical Trials Manager

2 months ago

Swansea, City and County of Swansea, United Kingdom Pharma Partners Recruitment Ltd Full time
Job Title: Clinical Trials Manager

Job Summary:

We are seeking an experienced Clinical Trials Manager to join our team at Pharma Partners Recruitment Ltd. As a Clinical Trials Manager, you will be responsible for the overall management of clinical trials, ensuring they are conducted in accordance with regulatory standards and company policies.

Key Responsibilities:

  • Design and author trial documentation and regulatory submissions, ensuring compliance with EU Clinical Trials Directive, Medical Device Directive, UK Clinical Trials Regulations, Principles of ICH-GCP, GDPR, and Research Governance Framework Legislation.
  • Monitor trial progress and performance, from participant identification and recruitment to data collection, ensuring timely and within-budget delivery.
  • Serve as the operational point-of-contact between the central study team and other operational staff, including CRA's/Senior CRA's.
  • Ensure the department maintains a high-quality, auditable system for standardizing trial conduct in accordance with regulatory standards.

Requirements:

  • Proven clinical trial experience, with a working knowledge of EU Clinical Trials Directive, Medical Device Directive, UK Clinical Trials Regulations, Principles of ICH-GCP, GDPR, and Research Governance Framework Legislation.
  • Working knowledge of BS EN ISO 14155.
  • A life science degree would be advantageous.

What We Offer:

A highly competitive salary and benefits package, reflecting the company's commitment to attracting and retaining top talent in the industry.