Clinical Trials Manager

6 days ago

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

We are seeking an experienced Clinical Trials Manager to join our Clinical and Application Research department at CyDen Ltd. As a key member of our team, you will be responsible for the overall management of clinical trials, ensuring they are conducted in accordance with contractual agreements, protocol, SOPs, regulatory and ethical requirements.

Key Responsibilities:

  • Design and author trial documentation and regulatory submissions
  • Monitor the progress and performance of multiple trials from participant identification and recruitment through to ensuring reliable data collection
  • Implement and modify established department procedures to ensure studies are conducted in accordance with contractual agreements, protocol, SOPs, regulatory and ethical requirements
  • Ensure trials are delivered on time and within budget constraints
  • Coordinate the work of the clinical and application research team across two sites, ensuring work scope and training needs are met
  • Ensure the department maintains its high-quality, auditable system for the standardization of trial conduct in accordance with all regulatory standards

Requirements:

  • BSc or equivalent in a biomedical, health, or life science field
  • Proven clinical trial experience, clinical trial management; CRO experience preferred
  • Experience in Phase I-IV trials; Phase II - III is preferred
  • Working knowledge of EU Clinical Trials Directive, Medical Device Directive, UK Clinical Trials Regulations, Principles of ICH-GCP, GDPR and Research Governance Framework Legislation
  • Strong, professional leadership experience

What We Offer:

  • Competitive rates of pay
  • 25 days holiday plus Bank holidays rising to 28 with length of service
  • 5% Company pension contributions
  • Company sick pay
  • Career development opportunities
  • Employee Assistance Programme
  • Cycle to Work Scheme

CyDen Ltd is committed to being an equal opportunities employer and values diversity.

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