Job summary
The Christie R&I team is seeking to appoint a candidate for a fixed period, to provide leadership and management of the quality management function supporting the Trust sponsored portfolio of research.
You will bring expertise and experience gained from working in a clinical research setting, a passion for efficient and high-quality clinical research and will enjoy collaborating with a close-knit team of colleagues.
As a subject matter expert, you will have thorough knowledge of clinical trials regulations and quality standards, and the ability to apply that knowledge in a dynamic research environment.
You will collaborate closely with clinicians, researchers, and a multi-disciplinary team of research management professionals to ensure the successful development and delivery of an expanding and varied portfolio of clinical trials and research projects. You will lead the ongoing development and continual improvement of existing, well-established quality control and quality assurance systems within the department.
Main duties of the job
Provide ongoing leadership and management in the design and implementation of Trust wide procedures as they relate to research sponsored by the Organisation, ensuring that they are robust, and concur with accepted best practice.
To function as a subject matter expert in good clinical practice and wider clinical trial regulations and standard.
Draft reports summarising status on issues, appraising outcomes, and providing progress reports for the Head of Department and a wide range of stakeholders as necessary.
Collate and present, qualitative, and quantitative information and lead appropriate analysis to make robust recommendations.
Analyse, interpret and present data to highlight issues, risks and support decision making.
About us
The Christie is one of Europe's leading cancer centres, treating over 60,000 patients a year. We are based in Manchester and serve a population of 3.2 million across Greater Manchester & Cheshire, but as a national specialist around 15% patients are referred to us from other parts of the country. We provide radiotherapy through one of the largest radiotherapy departments in the world; chemotherapy on site and through fourteen other hospitals; highly specialist surgery for complex and rare cancer; and a wide range of support and diagnostic services. We are also an international leader in research, with world first breakthroughs for over one hundred years. We run one of the largest early clinical trial units in Europe with over three hundred trials every year. Cancer research in Manchester, most of which is undertaken on the Christie site, has been officially ranked the best in the UK.
Job description
Job responsibilities
Duties and Responsibilities
1. Quality Management and Leadership
- Provide ongoing leadership and management in the design and implementation of Trust wide procedures as they relate to research, ensuring that they are robust, auditable and concur with accepted best practice.
- Responsible for making recommendations, providing advice and able to prepare strategic reports/briefings for the Head of Department, steering/reference groups and others as required.
- Responsible for ensuring the coordination of change control processes within the Trust sponsored research team.
- Work collaboratively with research support operations and governance teams by maintaining an awareness of quality issues and contributing to problem solving to ensure the delivery of high-quality research.
- Provides leadership for the design of study specific oversight plans.
- Implements a programme of internal audits as agreed with the Head of Quality. This includes conducting audits, writing reports, approving corrective/preventative actions (CAPA) and follow-up of CAPA implementation.
- Responsible for leading in the conduct of third-party suppliers/vendor qualification assessments (due diligence). Seeking advice and guidance where necessary.
- Support the Head of Quality in the preparation and hosting of mandatory regulatory inspections for Clinical Trials of Investigational Medicinal Products/ Medical Devices sponsored by the trust.
- Receive and respond to complex and occasionally sensitive research governance and reported quality related issues.
- Recognise and act upon departures from legislative and research governance requirements, including failure to follow protocols and/or SOPs, responding appropriately and escalating action as required.
- In collaboration with the Research Integrity and Governance Manager, take responsibility for leading in the assessment of serious breach assessments.
- Provide guidance to research operations on the interpretation of corporate and regulatory requirements (standard/policies/procedures) related to quality assurance and GCP.
- Maintain accurate quality management records that are ready for inspection by regulatory authorities on demand.
- Have joint responsibility for the effective management and maintenance of the electronic quality management system (Q Pulse database).
2. Service Improvement/Policy Development
- To develop and implement business processes and Standard Operating Procedures to ensure that the Trust conforms to the requirements of relevant legislation.
- Responsible for interpreting, proposing, and drafting changes to policies, guidelines, and service level agreements (SLAs) which impact the service.
- Maintain a good knowledge of emerging policies from government departments and external bodies which may impact the service.
- Contribute to strategic and contingency planning for the service, which may have an impact on other areas.
- Foster an environment for continuous improvement by sharing lessons learned through audits and inspections.
- Provide regular reports on quality trends, compliance risk, observations, and suggestions to senior management, as necessary.
- Work in partnership with the Research Integrity and Governance Manager to make recommendations for the priorities for quality improvement and develop new systems as part of a process of continuous quality improvment.
3. Risk Management
- Support the Head of Quality in ensuring that risk registers are managed and maintained within the Division by ensuring effective processes are implemented for the review of risks within the Trust sponsored research function
- Working in collaboration with the Sponsor Team develop and maintain knowledge of the portfolio of research sponsored by the Trust, identifying and responding to new research governance requirements to safeguard subjects, staff, and minimise organisational risk.
4. Communication.
- Provide, receive, and analyse highly complex, sensitive and contentious information and make judgements based on the
- Present complex information to a wide range of stakeholders in formal and informal settings.
- Responsible for providing management reports on Quality Management activities to departmental, Divisional and Trust Governance groups, as required.
- Provide specialist advice and support to other members of staff with regards to research conduct.
- Committed to working and engaging constructively with internal and external stakeholders on a range of business sensitive issues.
- Maintain strong relationships and positive communication channels with other key personnel.
- Develop and establish research relationships with key partners including academia, NHS, and commercial companies.
- External and internal representation of the R&I Division in specialist forums or consultative groups relating to research quality and compliance.
5. People Management and Development
- To support, motivate and develop staff within the wider research team including assisting with the development and delivery of relevant training.
- Influence, support, co-ordinate and take the initiative to obtain co-operation or agreement to alter ways of working, particularly where the need for change is not readily identified.
- Provide leadership and standards of best practice, promoting ethical and professional practice throughout the organisation.
- Provide specialist advice to internal and external investigators/ collaborators in the planning of compliant clinical research.
- Support the Head of Quality in shaping and delivering the quality systems and research governance training options available to best support all involved in research across the Trust.
- Considering the advice of functional leads, determine the quality system training needs of staff in relation to quality systems, deliver area specific training ensuring that there are mechanisms for effective oversight to facilitate departmental and functional leads in ensuring that all staff members are trained appropriately.
6. Learning and Development
- Ensure own professional knowledge is regularly updated and keep abreast of relevant developments, making effective use of learning opportunities and actively promoting the workplace as a learning environment.
- Maintaining and developing knowledge of national and local clinical and research quality initiatives.
- Participate in personal objective setting and review, including the creation of a personal development plan
- Actively seek mentorship/supervision/coaching to enable reflection and own personal development within the role.
Job description
Job responsibilities
Duties and Responsibilities
1. Quality Management and Leadership
- Provide ongoing leadership and management in the design and implementation of Trust wide procedures as they relate to research, ensuring that they are robust, auditable and concur with accepted best practice.
- Responsible for making recommendations, providing advice and able to prepare strategic reports/briefings for the Head of Department, steering/reference groups and others as required.
- Responsible for ensuring the coordination of change control processes within the Trust sponsored research team.
- Work collaboratively with research support operations and governance teams by maintaining an awareness of quality issues and contributing to problem solving to ensure the delivery of high-quality research.
- Provides leadership for the design of study specific oversight plans.
- Implements a programme of internal audits as agreed with the Head of Quality. This includes conducting audits, writing reports, approving corrective/preventative actions (CAPA) and follow-up of CAPA implementation.
- Responsible for leading in the conduct of third-party suppliers/vendor qualification assessments (due diligence). Seeking advice and guidance where necessary.
- Support the Head of Quality in the preparation and hosting of mandatory regulatory inspections for Clinical Trials of Investigational Medicinal Products/ Medical Devices sponsored by the trust.
- Receive and respond to complex and occasionally sensitive research governance and reported quality related issues.
- Recognise and act upon departures from legislative and research governance requirements, including failure to follow protocols and/or SOPs, responding appropriately and escalating action as required.
- In collaboration with the Research Integrity and Governance Manager, take responsibility for leading in the assessment of serious breach assessments.
- Provide guidance to research operations on the interpretation of corporate and regulatory requirements (standard/policies/procedures) related to quality assurance and GCP.
- Maintain accurate quality management records that are ready for inspection by regulatory authorities on demand.
- Have joint responsibility for the effective management and maintenance of the electronic quality management system (Q Pulse database).
2. Service Improvement/Policy Development
- To develop and implement business processes and Standard Operating Procedures to ensure that the Trust conforms to the requirements of relevant legislation.
- Responsible for interpreting, proposing, and drafting changes to policies, guidelines, and service level agreements (SLAs) which impact the service.
- Maintain a good knowledge of emerging policies from government departments and external bodies which may impact the service.
- Contribute to strategic and contingency planning for the service, which may have an impact on other areas.
- Foster an environment for continuous improvement by sharing lessons learned through audits and inspections.
- Provide regular reports on quality trends, compliance risk, observations, and suggestions to senior management, as necessary.
- Work in partnership with the Research Integrity and Governance Manager to make recommendations for the priorities for quality improvement and develop new systems as part of a process of continuous quality improvment.
3. Risk Management
- Support the Head of Quality in ensuring that risk registers are managed and maintained within the Division by ensuring effective processes are implemented for the review of risks within the Trust sponsored research function
- Working in collaboration with the Sponsor Team develop and maintain knowledge of the portfolio of research sponsored by the Trust, identifying and responding to new research governance requirements to safeguard subjects, staff, and minimise organisational risk.
4. Communication.
- Provide, receive, and analyse highly complex, sensitive and contentious information and make judgements based on the
- Present complex information to a wide range of stakeholders in formal and informal settings.
- Responsible for providing management reports on Quality Management activities to departmental, Divisional and Trust Governance groups, as required.
- Provide specialist advice and support to other members of staff with regards to research conduct.
- Committed to working and engaging constructively with internal and external stakeholders on a range of business sensitive issues.
- Maintain strong relationships and positive communication channels with other key personnel.
- Develop and establish research relationships with key partners including academia, NHS, and commercial companies.
- External and internal representation of the R&I Division in specialist forums or consultative groups relating to research quality and compliance.
5. People Management and Development
- To support, motivate and develop staff within the wider research team including assisting with the development and delivery of relevant training.
- Influence, support, co-ordinate and take the initiative to obtain co-operation or agreement to alter ways of working, particularly where the need for change is not readily identified.
- Provide leadership and standards of best practice, promoting ethical and professional practice throughout the organisation.
- Provide specialist advice to internal and external investigators/ collaborators in the planning of compliant clinical research.
- Support the Head of Quality in shaping and delivering the quality systems and research governance training options available to best support all involved in research across the Trust.
- Considering the advice of functional leads, determine the quality system training needs of staff in relation to quality systems, deliver area specific training ensuring that there are mechanisms for effective oversight to facilitate departmental and functional leads in ensuring that all staff members are trained appropriately.
6. Learning and Development
- Ensure own professional knowledge is regularly updated and keep abreast of relevant developments, making effective use of learning opportunities and actively promoting the workplace as a learning environment.
- Maintaining and developing knowledge of national and local clinical and research quality initiatives.
- Participate in personal objective setting and review, including the creation of a personal development plan
- Actively seek mentorship/supervision/coaching to enable reflection and own personal development within the role.
Person Specification
Qualifications
Essential
- Educated to post-graduate degree level equivalent specialised professional knowledge.
Desirable
- Evidence of Continuing Professional Development
Experience
Essential
- Previous experience in the management of quality assurance and / or regulatory compliance
- Experience of writing quality System policies and procedures
- Extensive experience in implementation of GCP
Desirable
- Experience within a teaching hospital setting
- Experience of developing strategies, policies, and business plans
Skills
Essential
- Ability to assess and interpret highly complicated and conflicting information and use judgement where appropriate
- Excellent verbal, written and presentation skills
- Possess developed persuasive, motivational, negotiating, empathic or re-assurance skills
- Ability to write and present complex reports and to critically analyse and communicate ideas in complex situations
- Good organisational and time management skills
- Excellent cross disciplinary / interagency communication skills and ability to facilitate collaborative working relationships
- Ability to influence and negotiate others in a challenging environment
- IT, information, project, and time management skills
- Ability to deal with difficult/ sensitive situations
- Ability to work as part of a team, demonstrated coaching/mentoring skills, good problem resolution skills,
- Able to develop and deliver staff training programmes and conference presentations
- Highly developed problem-solving skills and ability to respond to sudden unexpected demands.
- Strategic thinking --ability to anticipate and resolve problems before they arise.
Knowledge
Essential
- Comprehensive knowledge and understanding of standards and legislation that govern research practice in the NHS and processes.
- Comprehensive knowledge of Quality Systems
Desirable
- Knowledge of NHS R&D Strategy and NHS research agenda.
- Experience of risk management
Values
Essential
- Ability to demonstrate the organisational values and behaviours
Other
Essential
- Strong Personal integrity
- Innovative and positive approach
- Flexible and motivated team player
- Occasional travel to other sites
- High level of emotional intelligence
Person Specification
Qualifications
Essential
- Educated to post-graduate degree level equivalent specialised professional knowledge.
Desirable
- Evidence of Continuing Professional Development
Experience
Essential
- Previous experience in the management of quality assurance and / or regulatory compliance
- Experience of writing quality System policies and procedures
- Extensive experience in implementation of GCP
Desirable
- Experience within a teaching hospital setting
- Experience of developing strategies, policies, and business plans
Skills
Essential
- Ability to assess and interpret highly complicated and conflicting information and use judgement where appropriate
- Excellent verbal, written and presentation skills
- Possess developed persuasive, motivational, negotiating, empathic or re-assurance skills
- Ability to write and present complex reports and to critically analyse and communicate ideas in complex situations
- Good organisational and time management skills
- Excellent cross disciplinary / interagency communication skills and ability to facilitate collaborative working relationships
- Ability to influence and negotiate others in a challenging environment
- IT, information, project, and time management skills
- Ability to deal with difficult/ sensitive situations
- Ability to work as part of a team, demonstrated coaching/mentoring skills, good problem resolution skills,
- Able to develop and deliver staff training programmes and conference presentations
- Highly developed problem-solving skills and ability to respond to sudden unexpected demands.
- Strategic thinking --ability to anticipate and resolve problems before they arise.
Knowledge
Essential
- Comprehensive knowledge and understanding of standards and legislation that govern research practice in the NHS and processes.
- Comprehensive knowledge of Quality Systems
Desirable
- Knowledge of NHS R&D Strategy and NHS research agenda.
- Experience of risk management
Values
Essential
- Ability to demonstrate the organisational values and behaviours
Other
Essential
- Strong Personal integrity
- Innovative and positive approach
- Flexible and motivated team player
- Occasional travel to other sites
- High level of emotional intelligence
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).
