Quality, Risk And Compliance Manager in Cambridge, Cambridgeshire

ARM is currently partnered with one of the top 10 CROs globally who are currently seeking a Quality, Risk and Compliance Manager to work with them on an inside IR35 contract. They are offering a 6-month contract based in Cambridge, United Kingdom.

Responsibilities:

• Ensure compliance with applicable GxP and regional regulations throughout all stages of the clinical trial process.
• Provide expert guidance and support regarding the clinical trial process to stakeholders, including team members, sponsors, and regulatory authorities.
• Develop, review, and update Standard Operating Procedures (SOPs) and Work Process Documents (WPDs) to ensure alignment with regulatory requirements and best practices.
• Conduct training sessions and mentor staff on relevant processes and topics, ensuring their understanding and compliance with established procedures.

Requirements:

• Proven expertise in applicable GxP (Good Clinical Practices, Good Laboratory Practices, etc.) and thorough understanding of relevant regional regulations governing clinical trials.
• Communicate effectively, both orally and in writing, utilising appropriate medical and scientific terminology in various contexts such as reports, presentations, and correspondence.
• Extensive experience and comprehensive knowledge of the clinical trial process from initiation to closeout, including regulatory submissions, protocol development, and study execution.
• Demonstrated mastery of developing, implementing, and maintaining Standard Operating Procedures (SOPs) and Work Process Documents (WPDs) within a regulated environment.

Please apply to discuss further, alternatively you can contact me on +44 23 9245 8012 or email

Disclaimer:

This vacancy is being advertised by either Advanced Resource Managers Limited, Advanced Resource Managers IT Limited or Advanced Resource Managers Engineering Limited ("ARM"). ARM is a specialist talent acquisition and management consultancy. We provide technical contingency recruitment and a portfolio of more complex resource solutions. Our specialist recruitment divisions cover the entire technical arena, including some of the most economically and strategically important industries in the UK and the world today. We will never send your CV without your permission. Where the role is marked as Outside IR35 in the advertisement this is subject to receipt of a final Status Determination Statement from the end Client and may be subject to change.