Quality Assurance Manager - Cancer and Genomic Sciences

Position Details

Cancer Clinical Trials Unit, Institute of Cancer and Genomic Sciences

Location: University of Birmingham, Edgbaston, Birmingham UK

Full time starting salary is normally in the range £41,526 to £49,553. With potential progression once in post to £55,750 a year.

Grade 8

Full Time / Fixed Term Contract to 30 September 2023

Closing date 20 October 2019

Background

The Cancer Research UK Clinical Trials Unit (CRCTU), based within the University of Birmingham, is one of the largest UK Clinical Research Collaboration (UKCRC) registered trials units in the country. With an extensive portfolio of phase I to III trials in adults and children covering a wide range of disease sites; the Unit employs a multidisciplinary team of over 180 staff. CRCTU receives substantial core funding from Cancer Research UK.

The CRCTU Quality Management Team, led by the Quality Assurance Manager, is composed of quality assurance staff and clinical trial monitors. The team plays a pivotal role in the delivery of high quality, regulatory compliant clinical trials. Task undertaken by the team include maintenance of the Units Quality Management System (QMS), development of trial quality control documentation, review of trial other documentation, on-site monitoring and audit.

Job Summary

The Quality Assurance (QA) Manager plays a senior role in the CRCTU. They are responsible for developing, implementing and maintaining the QMS, establishing an internal and external risk based audit program, and managing a team of monitoring and quality management staff. They will play a key role in audits and inspections of the Unit. The QA Manager is expected to have a national profile as an expert in clinical trials quality systems.

Main Roles/Responsibilities

1. Develop, implement and maintain a clinical trial Quality Management System (QMS). Make decisions regarding the structure of the QMS, where necessary consulting with the CRCTU Director of Operations and other senior colleagues.

2. Facilitate the writing and review of Polices, Standard Operating Procedures (SOPs) and supporting documents. Act as a final reviewer for all SOPs and supporting documents to ensure that they have been written and reviewed in accordance with the QMS. With the CRCTU Director of Operations, and taking into account the advice of senior staff, determine which members of staff require training on each SOP document group. Decide on the most appropriate mechanism for creating these documents, where necessary contributing to personally writing documents.

3. Ensure that Polices, SOPs and supporting documents are reviewed as defined in the QMS.

4. With the CRCTU Director of Operations, and taking into account the advice of senior staff, determine which members of staff require training on each SOP document group. Maintain oversight of training to facilitate Team Leaders in ensuring all CRCTU staff members are trained on each SOP document group as specified in the QMS.

5. Establish an internal and external risk based audit programme. With the assistance of the Quality Assurance Officer plan the annual audit programme, personally perform audits and maintain an overview of programme delivery.

6. Manage the Quality Management Team. Maintain oversight of team finances and ensure that financial costings for monitoring service are provided for new clinical trials grant applications.

7. Provide a monitoring service for the CRCTU. Ensure that monitoring requirements for each clinical trial protocol are assessed. Ensure that Senior Monitor and Monitors perform on site monitoring in accordance with the trial specific Quality Management Plan and the QMS, where necessary personally perform on site monitoring.

8. As a member of the Operational Management Committee (OMC) of the CRCTU facilitate communication and an exchange of views on relevant management and policy issues, monitor trial progress and trial quality management. Report on quality management issues to the OMC. Advise the OMC on changes to the statutory and regulatory framework where necessary making recommendations for changes in practice within the CRCTU.

9. Assist, and when required take a lead, on the preparation and review of reports, inspection dossiers and other formal written documentation.

10. When required assist in the delivery of training (e.g. Good Clinical Practice (GCP), Quality Management, regulatory framework) to healthcare professionals, students and clinical trials staff.

11. Establish and maintain links with key staff at MHRA to ensure that there is effective liaison and advice when regulatory issues arise.

12. In discussion with appropriate staff members determine whether deviations are suspected major and/or critical findings or serious breaches of GCP and/or protocol and if necessary sign deviation form. For QMS related deviations determine and implement corrective and preventative action.

13. Liaise with auditors and (Medicines and Healthcare products Regulatory Agency (MHRA)) inspectors as required during audits and inspections of the CRCTU.

14. Develop a national profile as an expert in clinical trials quality systems. Contribute to local, national and international activities (e.g. within the University of Birmingham, Cancer Research UK, National Institute for Health Research, European Clinical Research Infrastructures Network, MHRA) through participation in national working parties, committees and by presenting at meetings.

15. Any other duties commensurate with the grading of the post.

16. Maintain confidentiality.

17. Support the delivery of clinical research in accordance with GCP, the Declaration of Helsinki, applicable legislation (including, but not limited to, the Medicines for Human Use Clinical Trials Regulations, Data Protection Act 1998, Human Tissue Act), the UK Policy Framework for Health and Social Care Research, 2017, Caldicott principals, and applicable NHS Trust and University policies and procedures, (including, but not limited to the University's Data Protection Policy, Information Security Policy and Code of Practice for Research) in order to protect the research subject and the quality of each study.

Person Specification

• A higher degree in a relevant biomedical or associated subject or a graduate with extensive experience within clinical trials quality management.

• Must be able to demonstrate experience in quality management within a quality assured environment (e.g. GCP, GMP, GLP, ISO9000 etc.)

• Experience of developing and/or maintaining quality management systems and writing SOPs is essential.

• Experience of staff management.

• A working knowledge of applicable regulations and guidance documents pertinent to clinical trials (e.g. Medicines for Human Use (Clinical Trials) Regulations, UK Policy Frameowrk for Health and Social Care Research, GCP etc.) is essential for this post.

• Must be able to demonstrate a good understanding of clinical research and audit procedures.

• Highly developed interpersonal, negotiation, presentation, and communication (written and verbal) skills are essential.

• Excellent IT skills. Familiarity with Microsoft Office: including PowerPoint and utilisation of advanced features of Word is essential. Experience with Microsoft Access and/or Q-Pulse document management system would be an advantage.

• Excellent organisational skills.

• Able to work on own initiative and problem solve.

• Must demonstrate a critical and intelligent attention to detail with high standards of accuracy.

• Proven ability to work to strict deadlines.

• Must be able to work independently and as part of a team.

• Ability to travel nationally and internationally (on occasion) is essential.

Informal enquiries can be made to Sarah Bowden (email s.j.bowden@bham.ac.uk )

Valuing excellence, sustaining investment

We value diversity at The University of Birmingham and welcome applications from all sections of the community