Job title: Clinical Trials Manager
A Medical Devices business in Swansea are looking for a Clinical Trial Manager to join their team. In this role you will be responsible for all aspects of clinical trial management for the companies portfolio.
Responsibilities:
- Duties will include designing and authoring trial documentation and regulatory submissions, plus monitoring the progress and performance of multiple trials from participant identification and recruitment through to ensuring reliable data collection.
- Serves as the operational point-of-contact between the central study team and other operational staff including CRA’s/Senior CRA’s.
- Responsible for ensuring trials are delivered on time and within budget constraints.
- You will ensure the department maintains its high quality, auditable system for the standardization of trial conduct in accordance with all regulatory standards.
Requirements:
- Proven clinical trial experience
- 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
- Working knowledge of BS EN ISO 14155
- A life scienced degree would be advantageous.
Salary and benefits:
A highly competitive salary and wider benefits scheme is on offer.
To apply for this position or hear further details then please contact Freddie Hill via Freddie.hill@pharma-partners.co.uk