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Clinical Trials Manager

2 months ago

Swansea, City and County of Swansea, United Kingdom Cyden Ltd Full time
Job Summary

We are seeking a highly skilled 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 overseeing all aspects of clinical trial management, ensuring the successful execution of trials from participant identification to data collection.

This is a challenging and rewarding role that requires strong leadership skills, attention to detail, and the ability to work effectively in a fast-paced environment. If you have a passion for clinical research and a proven track record of managing clinical trials, we encourage you to apply.

Key Responsibilities
  • Design and author trial documentation and regulatory submissions
  • Monitor the progress and performance of multiple trials
  • 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
  • Develop operational project plans and manage trial associates, investigators, and other trial personnel
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

CyDen Ltd is committed to being an equal opportunities employer and values diversity. We offer a competitive salary, 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 and Cycle to Work Scheme.