Job overview
We are looking for an enthusiastic and dynamic Quality Assurance Manager with the Directorate of Research & Innovation (R&I). The post holder will be specifically responsible for developing, monitoring and assessing systems to ensure that research at GOSH/ICH is compliant with the UK Policy Framework for Health and Social Care, Medicines for Human Regulations, Human Tissue Act, Data Protection Act and the International Conference on Harmonisation Good Clinical Practice Guidelines (ICH-GCP). The post holder will work in the R&D Office and Clinical Research Facility (CRF). The post holder will ensure studies are setup and managed in line with national and local procedures and policies.
The post holder will be expected to work across the R&I Division. They will work with sponsors, research teams, GOSH Clinical Directorates and other teams as required on providing quality assurance oversight, through implementing and maintaining systems and processes to assure the quality of clinical research undertaken across the organisation. The post holder will help to share best practice and ensure efficiency of the Quality Assurance (QA) function across R&I. The post holder will ensure that there is a well-maintained clinical research quality control system for all standard operating, procedures, policies and other key documents across the Directorate and for supporting and annual audit programme and other external and internal audits working alongside the Clinical Trials, Research Governance and CRF teams.
The post holder will maintain up to date knowledge of appropriate regulations and guidelines and will support the Directorate in preparations for external audits and regulatory inspections.
You will have experience of working in a clinical trial environment, with experience of monitoring or managing clinical trials. You will need to be able to demonstrate evidence of managing, developing and implementing QA systems. You will have strong negotiation skills with the ability to communicate with and influence senior clinical academic staff along with various stakeholders and funders.
You will be expected to work closely with academics and clinicians who are world leaders in their fields and will be exposed to an exciting array of cutting edge projects.
You will have a post-graduate qualification or equivalent work experience and will have significant relevant experience in a research environment.
We offer a friendly and challenging working environment with a strong commitment to personal professional development. You will work across the Directorate of Research and Innovation.
Informal discussions are welcomed, please contact Vanshree Patel, Associate Director R&I, (Governance & Compliance)
Main duties of the job
This post is responsible for providing robust Quality Assurance oversight for all clinical research across the Trust.
The post holder will be expected to work across the Research and Innovation (R&I) Directorate and wider Trust to ensure all clinical research is undertaken in accordance with relevant guidelines and legislation. The post holder will be part of a team responsible for ensuring clinical research quality assurance across the Directorate and Trust through developing, implementing and maintaining systems and processes to assure the quality of clinical research undertaken across the organisation. The post holder will help to share best practice and ensure efficiency of the Quality Assurance (QA) function across the Trust. The post holder will be responsible for ensuring that there is a well-maintained clinical research quality control system for all standard operating, procedures, policies and other key documents across the Directorate and for undertaking an annual audit programme working alongside the Clinical Trials, Research Governance and CRF teams. The post holder will be responsible for the development, implementation and maintenance of systems to assure the quality of clinical research undertaken within the Trust, in accordance with the International Conference on Harmonisation Good Clinical Practice Guidelines (ICH-GCP), the UK policy framework for health and social care research, and the Medicines for Human Use (Clinical Trials) Regulations 2004 and subsequent amendments.
The post holder will coordinate all necessary preparation for external audit and regulatory inspection ( by the Medicines and Healthcare Products Regulatory Agency (MHRA)).
The post holder will be expected to take a key leadership role nationally within the UKCRF Network, promoting the role of QA in research delivery.
Working for our organisation
We are keen to make our workforce as diverse as the communities we serve, and we hope to attract applications from underrepresented groups, including people with Black, Asian and Minority Ethnic heritage, people with a disability, and people from LGBTQ+ communities. By growing an ever more diverse workforce, we’ll have a greater range of perspectives and knowledge, meaning that we can provide the children and young people at our hospital with even better care.
Our hospital is committed to creating an environment that is open and inclusive. Our staff are encouraged to engage with colleagues through the following networks: REACH (Race, Ethnicity and Cultural Heritage) ENABLED (Enhancing Abilities & Leveraging Disabilities Network), PRIDE and Women’s networks; all of which are sponsored by a member of our Executive Management Team.
We want to ensure that all of our people, regardless of their background, are seen and heard. We want to attract applicants that share our commitment to inclusion and that understand diversity is a strength that is embraced and valued.
Detailed job description and main responsibilities
Please see the Job Description attached.
This job description is intended as an outline of the areas of activity and can be amended in the light of the changing needs of the service and will be reviewed as necessary in conjunction with the post-holder.
Person specification
Values
Essential criteria
* Gosh Values
* Knowledge and understanding of diverse backgrounds and perspectives.
* Understanding of Diversity and Inclusion challenges in the workplace.
Academic/Professional qualification/Training
Essential criteria
* Experience and knowledge of clinical research or health service quality management
* Postgraduate qualification or equivalent work experience
* Masters degree or appropriate professional qualification in a scientific discipline
* Evidence of continuous professional/personal development
* Formal training/certification in Quality Management and Audit or equivalent work experience
Experience/Knowledge
Essential criteria
* Experience of working in a clinical trial environment in either a pharmaceutical company, NHS Trust or university
* Either practical experience of auditing clinical trial activity or practical experience of the research process or direct involvement in the management of clinical trials.
* Experience of managing, developing and implementing quality management systems.
* Experience in hosting or participating in regulatory inspections
* Excellent knowledge of ICH GCP, and EU and UK legislation and standards. Excellent understanding of research management and governance processes. Able to providing training in GCP to others.
* Knowledge of a broad range of clinical research including clinical trials of investigational medicinal products in all phases
* Significant experience of staff management and successfully managing a team
* Experience of developing and implementing policies and standard operating procedures
* Computer literate with word processing and spreadsheet skills
Desirable criteria
* Experience of working in the NHS and an understanding of the NHS R&D structure and functions.
Skills/Abilities
Essential criteria
* Excellent verbal and written communication skills, ability to set expectations clearly
* Ability to analyse and act on complex information in order to facilitate change
* Ability to make complex decisions
* Ability to plan and develop quality strategy plans using analysis of complex performance data to put forward service development options in a clear and concise way
* Able to write business cases for service developments. Ability to present business plans, including data to a variety of audiences, communicating at all levels of the organization
* Excellent interpersonal skills, ability to negotiate and influence others at all levels to initiate change, and manage conflict
* Ability to plan, prioritise and manage work within set time scales and to act autonomously
* Ability to work as part of a team, taking the lead where appropriate and an ability and willingness to share leadership
* Ability to make decisions and take charge of events when required
* Ability to work across organizational boundaries
* High attention to detail