Job summary
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.
o To coordinate and lead on any sponsor audits / regulatory inspections.o To design and deliver SOP training to all members of the team as requiredo To support Research Managers as required.o To lead on QA projects as directed by CCTU Senior Management as required.
About us
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:
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,gastrointestinaland oral disease. It has world class support services including critical care, imaging, nuclearmedicineandpathology.
Weare 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.
Job description
Job responsibilities
For the full Person Specification and more informationregardingthe 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 recentNHS staff surveyUCLH 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 UCLHa great placeto work, visit:Why Choose UCLH?
Job description
Job responsibilities
For the full Person Specification and more informationregardingthe 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 recentNHS staff surveyUCLH 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 UCLHa great placeto work, visit:Why Choose UCLH?
Person Specification
Knowledge and Qualifications
Essential
- 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
- Formal training/ certification in Quality Management and/or monitoring clinical trials.
Experience
Essential
- 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
- 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
- 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
- Willing to provide support to other areas in setting up a Quality Management and audit system
Communication
Essential
- 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
- 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
- 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
Person Specification
Knowledge and Qualifications
Essential
- 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
- Formal training/ certification in Quality Management and/or monitoring clinical trials.
Experience
Essential
- 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
- 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
- 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
- Willing to provide support to other areas in setting up a Quality Management and audit system
Communication
Essential
- 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
- 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
- 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
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
Additional information
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
