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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 Trial Manager

About the Role:

We are seeking an experienced Clinical Trial Manager to join our team at Pharma Partners Recruitment Ltd. As a Clinical Trial 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 Authorize Trial Documentation: Develop and implement trial protocols, case report forms, and other essential documents to ensure compliance with regulatory requirements.
  • Monitor Trial Progress: Oversee the progress of multiple trials, from participant identification and recruitment to data collection and analysis.
  • Operational Point-of-Contact: Serve as the primary point of contact between the central study team and other operational staff, including Contract Research Associates (CRAs) and Senior CRAs.
  • Ensure Trial Delivery: Guarantee that trials are completed on time and within budget constraints, while maintaining high-quality standards.
  • Regulatory Compliance: Ensure the department adheres to all regulatory standards, including EU Clinical Trials Directive, Medical Device Directive, UK Clinical Trials Regulations, Principles of ICH-GCP, GDPR, and Research Governance Framework Legislation.

Requirements:

  • Proven Clinical Trial Experience: A minimum of [X] years of experience in clinical trial management, with a strong understanding of regulatory requirements.
  • Regulatory Knowledge: Working knowledge of EU Clinical Trials Directive, Medical Device Directive, UK Clinical Trials Regulations, Principles of ICH-GCP, GDPR, and Research Governance Framework Legislation, with the ability to apply these to the coordination of clinical trials.
  • Industry Knowledge: Familiarity with BS EN ISO 14155 and a life science degree would be advantageous.

What We Offer:

A highly competitive salary and benefits package, along with opportunities for professional growth and development in a dynamic and supportive environment.