Clinical Trials Manager

5 days ago

Swansea, City and County of Swansea, United Kingdom The Recruitment Co. Full time
Job Summary

The Recruitment Co. is seeking a highly experienced Clinical Trials Manager to join our client's expanding team. As a world-leading manufacturer of high-quality technical products, we are looking for a professional with a strong background in clinical trial management to lead our clinical and application research team.

Key Responsibilities
  • Design and Author Clinical Trial Documentation: Develop and implement clinical trial protocols, case report forms, and other relevant documentation to ensure compliance with regulatory requirements.
  • Monitor Trial Progress and Performance: Oversee the progress and performance of multiple trials, from participant identification and recruitment to data collection and analysis.
  • Regulatory Compliance: Ensure that all clinical trials are conducted in accordance with contractual agreements, protocol, SOPs, regulatory, and ethical requirements, including ICH-GCP guidelines.
  • Team Leadership: Coordinate the work of the clinical and application research team across two sites, ensuring work scope and training needs are met, and inspiring, motivating, and increasing employee productivity.
  • Quality Assurance: Maintain a high-quality, auditable system for the standardization of trial conduct in accordance with all regulatory standards.
Requirements
  • Education: BSc or equivalent in a biomedical, health, or life science field.
  • Experience: Proven clinical trial experience, clinical trial management; CRO experience preferred.
  • 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.
  • Leadership Experience: Strong, professional leadership experience.
Key Objectives/KPI's
  • Design Clinical and Application Research Studies: Develop and implement clinical and application research studies to meet business objectives.
  • Author Clinical Investigation Plans and Final Study Reports: Develop and implement clinical investigation plans and final study reports to ensure compliance with regulatory requirements.
  • Statistical Analysis: Conduct statistical analysis of clinical data to inform business decisions.
  • Communication: Prepare and present clinical data and research findings to stakeholders.

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