Research Quality Assurance Manager

Detailed job description and main responsibilities

1.0 Quality Management and Leadership
• Manage the operational delivery of the Trust Sponsored Research Quality Management System.
• Provide specialist expertise and operational leadership in the implementation, maintenance and continual improvement of research quality management processes.
• 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.
• Implement a programme of risk-based quality assurance and assurance
activities, including audits, quality reviews, compliance assessments and
thematic reviews
• Responsible for leading in the conduct of third-party suppliers/vendor qualification assessments (due diligence) related to Trust sponsored studies. Seeking advice and guidance where necessary.
• 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.
• Support quality reviews and investigations relating to significant quality and compliance concerns, escalating findings appropriately in accordance with Trust procedures.
• Provide guidance to research operations/governance teams 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.
• Support the implementation and ongoing evaluation of risk-based quality management approaches across the Trust sponsored research portfolio.
• Contribute to the identification and review of critical-to-quality factors and quality risks throughout the research lifecycle.
• Maintain oversight of quality events, deviations, audit findings, CAPAs, lessons learned and compliance trends across the sponsored portfolio.
• Monitor quality metrics and key performance indicators and provide reports to support organisational assurance.
• Ensure controlled documents are reviewed and maintained in accordance with document governance requirements.
• Support the implementation and monitoring of risk-based quality management processes across the sponsored research portfolio.
2.0 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 (SLA's) which impact the service.
• Maintain a good knowledge of emerging policies from government departments and external bodies which may impact the service.
• Promote Quality by Design principles through the development, review and continual improvement of quality systems and research processes
• Contribute to strategic and contingency planning for the service, which may have an impact on other areas.
• Foster an environment for continuous improvement through ensuring that lessons learned through audits and inspections are shared within the Department and beyond as necessary.
• Provide regular reports on quality trends, compliance risk, observations and suggestions to senior management as necessary.
• Work collaboratively with Research Governance, Sponsorship, Research Delivery and Support Services to identify and implement quality improvement priorities arising from audits, compliance reviews, quality metrics and lessons learned.
3.0 Risk Management
• Support the departmental lead in ensuring that risk registers are effectively managed and maintained within the Division by ensuring effective processes are implemented for the review of risks within the Trust sponsored research function
• Maintain oversight of quality and compliance risks identified across the Trust sponsored research portfolio, ensuring appropriate escalation and monitoring through established governance processes.
4.0 Communication
• Provide, receive and analyse highly complex, sensitive and contentious
information and make judgements based on the information.
• 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.
• Present audit findings, compliance trends and quality improvement
recommendations in a constructive and solutions-focused manner.
• Develop effective working relationships with investigators, research teams and support services to promote engagement with quality improvement activities.
• Produce routine and ad hoc quality assurance reports for governance groups and senior stakeholders
• 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.
• Represent the Research Quality, Assurance and Regulatory Compliance team at relevant quality. Regulatory and governance forums as delegated.
5.0 People Management and Development
• Provide professional support, coaching and subject matter expertise to research staff in relation to quality management systems, Good Clinical Practice, audit readiness and compliance requirements.
• Where required, supervise designated staff, trainees or project-based quality resources.
• 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 cannot easily be 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.
• 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.
6.0 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.
• Committed to working and engaging constructively with internal and external stakeholders on a range of business sensitive issues



Person specification

Qualifications



Essential criteria

• First degree in life sciences discipline or equivalent specialised professional experience

Desirable criteria

• Post graduate qualification in related discipline
• Evidence of Continuing Professional Development

Experience



Essential criteria

• Previous experience in the management of quality assurance and / or regulatory compliance in a research setting within the NHS or Academic setting
• Experience of writing quality System policies and procedures
• Experience in implementation of GCP

Desirable criteria

• Experience of developing strategies, policies, and business plans

Skills



Essential criteria

• 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
• Must be able to use initiative to decide relevant actions and make recommendations to Sponsor/Manager, with the aim of improving deliverables and compliance to policies
• Strategic thinking - ability to anticipate and resolve problems before they arise

Knowledge



Essential criteria

• Detailed knowledge of ICH E6(R3) Good Clinical Practice principles
• Knowledge of UK Clinical Trials Regulations and associated guidance
• Knowledge of Quality Management Systems and quality assurance methodologies
• Knowledge of risk-based quality management principles
• Knowledge of CAPA management and root cause analysis methodologies
• Knowledge of audit, assurance and inspection processes
• Understanding of sponsor responsibilities within NHS sponsored research
• Knowledge of research governance frameworks applicable to clinical research

Desirable criteria

• Knowledge of NHS R&D Strategy and NHS research agenda
• Experience of risk management
• Knowledge of Quality by Design principles
• Knowledge of electronic quality management systems
• Knowledge of computerised systems and data integrity principles

Values



Essential criteria

• Ability to demonstrate the organisational values and behaviours

Other



Essential criteria

• Strong Personal integrity
• Innovative and positive approach
• Flexible and motivated team player
• Occasional travel to other sites
• Elevated level of emotional intelligence

The closing date for this post may be extended if there are insufficient applicants or brought forward if there is a high volume of applicants.

Application Information - If you have not heard from us within four weeks of the closing date, I regret that on this occasion your application will have been unsuccessful.

Sponsorship Information - We are an approved sponsoring organisation. Applications will be considered from applicants requiring sponsorship alongside all other applications. Please be aware, not all roles are eligible for sponsorship. You can review the list of eligible role and requirements on the