Study Monitor (Clinical Operations)
Cyden
- Swansea
- £30,000 per year
- Permanent
- Full-time
- Motivate research team.
- QA/QC investigators daily activities; ensuring compliance with CIP and regulatory compliance.
- Ensure research staff achieve targets and deliverables in a timely manner.
- Conduct detailed audits and trend analysis on key elements of trial execution; bridge the gap.
- Assume full study monitor responsibility.
- Procure, store, and disseminate study supplies (dispensing and accountability), including investigational devices.
- Induct, train and mentor new department personnel, including competency testing.
- Identify and devise new training materials as deemed appropriate.
- Identify and devise new departmental SOPs/WI and template documentation, as deemed appropriate
- Solid degree in scientific subject
- Experience in a clinical research setting; proven clinical trial experience.
- 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 with proven ability to apply these to the coordination of clinical trials.
- Understanding of current EU Medical Device Regulation
- Working knowledge of BS EN ISO 14155 is preferred.
- Experience working effectively in a team/matrix environment.
- Proven ability to manage multiple priorities and communicate effectively.
- Excellent Organisational Skills.
- Eye for Detail. You operate with a strong sense of due diligence.
- Excellent Communication Skills. An inspiring communicator. You communicate clearly and concisely. You are effective in conflict resolution. You have the ability to handle different views to find a sensible way forward for a project. You communicate with a collaborative approach.
- Diligent. Attentive and assiduous. Thoroughly investigate and verify issues.