job details for:
Clinical Research - Clinical Quality Assurance Manager Jobs - Cambridgeshire

Clinical Research - Clinical Quality Assurance Manager Jobs - Cambridgeshire (Job Ref: WR/JOBS/19158-7109)

Job Description :

Flame Pharma - Clinical Research - Clinical Quality Assurance Manager Job - Cambridgeshire:

Job Summary

An opportunity for a Quality Auditor Manager to work with one of the largest pharmaceutical services companies in the world has arisen for a talented and skilled Clinical Quality Auditor Manager.

If you are looking for a challenge and to accelerate your Clinical Quality Auditor Manager career by working on multiple projects in the Clinical quality auditing department for world leading clients, then this position is for you.

Job Title

Clinical Quality Auditor Manager

Background

Due to expansion, our client are looking to recruit a CQA Manager to review and assess company activities to assure that contractual obligations to client companies are met, and that clinical trials are conducted and reported in accordance with ICH Guidelines.

Key Responsibilities

• Plan and deliver audit programs for a number of clients and projects, and provides expert advice to project personnel on GCP issues
• Ensure all types of project-related audits are undertaken, including support for client audits and regulatory inspections
• Involved in specialist audits, including system and facility audits, and be involved in mentoring CQA Auditors 1 and 2
• Perform audits of study files, trial sites, and other audits as requested, to meet the requirements of audit plans
• Perform compliance reviews of documents, including CQA review of ICFs
• Provide CQA consultancy for selected clients and projects
• Responsible for planning and delivery of contracted and internal site and file audit programs
• Leads directed (for-cause) audits
• Leads facility, vendor and sub-contractor assessments
• Responsible for project- or client-related bids and contracts development (EU only)
• Design and conduct single function, internal system audits, under guidance of global internal systems auditor
• Lead preparation and hosting of client system audits
  Support regulatory inspections
• Mentor CQA Auditors 1 and 2 in agreement with the CQA Regional Head

Qualifications and Experience

• Life Science degree or equivalent qualification and relevant experience
• Detailed knowledge of ICH-GCP and appropriate regional clinical research regulations and guidelines
• Experience of approx 50 - 80 site audits in a clinical research environment (can include auditing in GCP environment)
• Performed and led a range of project-based audits to the standards required by CQA Management
• Conducted facility audits, vendor and sub-contractor assessments
• Involvement in conducting process and system audits

Benefits

With this position comes an attractive benefits package that you associate with a world leader, including pension, healthcare, plus a salary from £35,000.

Key Words

Manager, Clinical quality Auditor Clinical Research, Clinical Trials, Medical, Clinical, CRO, Study Management, Clinical Management, Pharmaceutical, Career, Research

For further information on this vacancy, please contact Flame Pharma on 0800 085 0858