Quality Assurance Manager

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Job overview

The Cancer Clinical Trials Unit at UCLH is looking to recruit a Quality Assurance Manager on a 12 month FTC.

The QA Manager an autonomous specialist working within the multi-disciplinary team. They will lead on all quality initiatives with the CCTU, developing, implementing and maintain quality systems and processes, and ensuring that all clinical research within CCRU is delivered in accordance with GCP.

They will line manage a number of staff, including a Quality Assurance Assistant who will support with quality projects and directives. The QA Manager will also provide leadership and support to the team as a whole.

Excellent communication and a proven ability to implement change, or new systems, are essential for the role. The ideal candidate will be dynamic, with excellent verbal and written communication skills and experience of managing/leading teams within the NHS setting. They will have significant experience in quality assurance and clinical trials and an in-depth knowledge of GCP and research governance.

Main duties of the job

The QA Manager will work autonomously to ensure systems and processes are in place to ensure Clinical Trials are delivered within local, national and international standards.
• To coordinate and lead on any sponsor audits / regulatory inspections.
• To design and deliver SOP training to all members of the team as required
• To support Research Managers as required.
• To lead on QA projects as directed by CCTU Senior Management as required.

Working for our organisation

University College London Hospitals NHS Foundation Trust (UCLH) is one of the most complex NHS trusts in the UK, serving a large and diverse population. We provide academically led acute and specialist services, to people from the local area, from throughout the United Kingdom and overseas. Our vision is to deliver top-quality patient care, excellent education, and world-class research.

We provide first-class acute and specialist services across eight sites:

• University College Hospital (incorporating the Elizabeth Garrett Anderson Wing)

• National Hospital for Neurology and Neurosurgery

• Royal National ENT and Eastman Dental Hospitals

• University College Hospital Grafton Way Building

• Royal London Hospital for Integrated Medicine

• University College Hospital Macmillan Cancer Centre

• The Hospital for Tropical Diseases

• University College Hospital at Westmoreland Street

We are dedicated to the diagnosis and treatment of many complex illnesses. UCLH specialises in women's health and the treatment of cancer, infection, neurological, gastrointestinal and oral disease. It has world class support services including critical care, imaging, nuclear medicine and pathology.

We are committed to sustainability and have pledged to become a carbon net zero health service, embedding sustainable practice throughout UCLH. We have set an ambitious target of net zero for our direct emissions by 2031 and indirect emissions by 2040.

Detailed job description and main responsibilities

For the full Person Specification and more information regarding the main responsibilities of this role, please refer to the attached Job Description.

Cancer Services sits within the Surgery and Cancer Board. It incorporates comprehensive outpatient, day care, and ambulatory care and inpatient services for the specialities of inpatient and outpatient oncology and Haematology.

The Cancer Clinical Trials Unit office is based in 250 Euston Rd and comprises of three main areas: Haematology, Oncology and Paediatric Oncology and it supports activity in the local Clinical Research Facility and the North Thames Local Comprehensive Research Network and Experimental Cancer Centre. Each group comprises teams of research nurses, clinical trial practitioners and data managers and provides support to local Investigators wishing to conduct clinical trials and other high quality clinical research projects within UCLH. Each team supports a process for agreeing a portfolio of research and ensures that trials are conducted to the highest standards and in accordance with UK legislation and the R&D Governance Framework. The aim of the Unit is to effectively use resources so as to ensure that patients have access to entry into clinical trials, as appropriate, and maintain the highest quality of care for patients.

Come and be a part of the best NHS trust in England to work for, according to our staff*

* UCLH top trust to work at in England - In the most recent NHS staff survey UCLH had the highest percentage of staff who said they would recommend us as a place to work, out of all general acute or acute/community NHS trusts in England - for the third year in a row.

UCLH recognises the benefits of flexible working for staff - To find out more, visit: Flexible working.

To discover more about what makes UCLH a great place to work, visit: Why Choose UCLH?

Person specification

Knowledge and Qualifications



Essential criteria

• First degree or equivalent in clinical or life science related subject.
• Master's Degree or equivalent experience
• Certified training in Good Clinical Practice.
• Excellent knowledge of the Research Governance Framework for Health and Community Care, Medicines for Human Use (Clinical Trials) Regulations, Adults with Incapacity Act, Data Protection Act, Governance Arrangements for Research Ethics Committees and Human Tissue Act.
• Knowledge of local, national and international developments in clinical research policy.

Desirable criteria

• Formal training/ certification in Quality Management and/or monitoring clinical trials.

Experience



Essential criteria

• Significant experience of undertaking, coordinating or managing clinical research
• Experience of developing and implementing QA procedures in a clinical research environment.
• Experience of undergoing an inspection and audit by an external authority.
• Relevant experience at a Band 7 or equivalent
• Previous NHS experience or equivalent work experience
• Previous experience of formal and informal teaching of staff
• Strong understanding of multidisciplinary issues and commitment to multi disciplinary working

Desirable criteria

• Experience of managing QA systems for clinical trials in Phases I, II and III
• Experience of providing training in GCP/GLP
• Managerial experience

Skills and Abilities



Essential criteria

• Excellent verbal and written communication skills
• Excellent interpersonal skills
• Able to interpret complex information in order to facilitate change
• Good negotiating skills and the ability to influence others at all levels to initiate change
• Confident in delivering sensitive information with tact and diplomacy
• Confident in making autonomous professional decisions relating to QA
• Good IT skills and confident using Word, Excel, PowerPoint, Access
• Good organizational and time management skills
• Able to pay attention to detail

Desirable criteria

• Willing to provide support to other areas in setting up a Quality Management and audit system

Communication



Essential criteria

• Demonstrates commitment to multi-disciplinary working
• Able to work across organisational and professional boundaries
• Able to negotiate effectively with different disciplines
• Understanding of relevant national strategy / policy and how this relates to the service

Personal and People Development



Essential criteria

• Demonstrates a clear vision of the role and service.
• Decision making skills
• Able to resolve complex problems
• Effective communicator, in writing, verbally & electronically
• Presentation skills

Specific Requirements



Essential criteria

• Proven ability to work under own initiative
• Diplomatic and calm under pressure
• Proven ability to prioritise own workload and work to deadlines
• Team Player
• Enthusiastic

At UCLH, we have a real 'One Team' ethos, and our values - safety, kindness, teamwork and improving, are central to the way we work. This is supported by our staff, who voted us as the #1 NHS Acute Trust to work for in the whole of England.

At UCLH we take equality of opportunity seriously and are committed to being a diverse and inclusive employer, with a culture that creates a real sense of belonging and trust. It is our fundamental aim, to recruit, retain and promote a diverse mix of people who are representative of our local communities. Applications are encouraged from candidates of all backgrounds, cultures, and perspectives to support our world class research, innovation and creativity.

UCLH recognises the benefits of flexible working for staff and has a dedicated policy which allows staff to apply for flexible working right from the beginning of employment. For more information please go to:

We offer our permanent staff an interest free season ticket loan for travel, all our staff have access to free independent and confidential support, large retail discounts, a staff discount platform, cycle to work scheme and on-site accommodation to name a few.

Additionally, UCLH Arts and Heritage's staff wellbeing programme, Creative Comfort, offers a variety of ways to engage with the arts as a member of UCLH staff. You can try out the weekly choir, weekly art club and join the Culture Club for exclusive access to free and discounted tickets for opera, exhibitions, theatre and more.

We recognise, reward and thank colleagues by nominating them for our annual Celebrating Excellence Awards, which are funded by UCLH Charity.

We are also members of which offers discounts on high street retail stores, offers on travel deals, and also to take advantage of cash back schemes.

This vacancy may close before the current listed closing date. You are advised not to delay submitting your completed application.

Please note that all correspondence regarding your application will be via email. The emails will be sent to you via TRAC.jobs and not via NHS Jobs, we encourage you to check your inbox regularly.

Please note that if you have not heard from us within 3 weeks of the closing date of the advert to assume that you have not been shortlisted on this occasion.

The Trust uses electronic new starter forms on Trac to collect personal details. Information collected is securely stored and used to set up the employee record on the ESR HR system.

For further support on submitting an application please refer to the NLPSS Applicant Toolkit:


Employer certification / accreditation badges

Applicant requirements

The postholder will have access to vulnerable people in the course of their normal duties and as such this post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2020 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service to check for any previous criminal convictions.



Documents to download

• Job Description (PDF, 480.4KB)
• Functional Requirements (PDF, 262.3KB)
• UCLH Values (PDF, 860.9KB)