Clinical Trials Manager

Clinical Trials Manager

£45,000

Swansea

Hybrid working

Yolk Recruitment has a new opportunity for a Clinical Trials Manager to join an expanding manufacturer who are leading competitors within the Medical Sector.

This role reports directly to the Director of Clinical Affairs and is an opportunity for an established Clinical Trials Manager to join a secure company who offer professional growth and development.

Duties will include designing plus 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. This will be achieved through implementing/modifying established department procedures to ensure studies are conducted in accordance with contractual agreements, protocol, SOPs, regulatory and ethical requirements including ICH-GCP guidelines. You will also be responsible for ensuring trials are delivered on time and within budget constraints.

What you will be doing as Clinical Trials Manager:

• Design clinical and application research studies.
• Author Clinical Investigation Plans (CIP) and Final Study Reports (FSR)
• Statistically analyse clinical data
• Draft clinical manuscripts for publication
• Prepare abstracts, power-point presentations and posters for submission to scientific conferences.
• Understand how clinical data can best assist product launch/sales.
• Conduct audits and trend /gap analysis on key elements of trial execution.
• Assume PI responsibility for all clinical trials.
• Maintain up-to-date knowledge of relevant industry guidelines.
• Oversee activity of trial sites
• Contribute to all trial management activities including budgeting.
• Develop operational project plans.
• Manage trial associates, investigators, and other trial personnel to ensure personnel are up to date with relevant information or issues. Delegate workloads accordingly.

The skills you will bring as Clinical Trials Manager:

• BSc or equivalent in biomedical, health of 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 with proven ability to apply these to the coordination of clinical trials.
• Understanding of current EU Medical Device Regulation
• Evidence of preparing regulatory and ethics submissions, writing/amending Clinical Investigation Plans, Patient Information Forms and electronic Case Report Forms, plus other relevant trial management documentation
• Working knowledge of BS EN ISO 14155
• Strong, professional leadership experience

If you feel you have the skills, experience and passion to be successful in this Clinical Trials Manager role apply now

*Please note, whilst we do our best to contact all candidates, due to the high number of applications we receive we cannot guarantee this for every role. If you have not heard anything from us within 7 days of applying - then unfortunately you have been unsuccessful. Please keep an eye on our website for more opportunities.