Detailed job description and main responsibilities

Quality Management and Improvement

• Conduct the day-to-day management of the QMS modules including document management, audit management, change management and asset management.
• Contributing to the development of the QMS, with a focus on electronic solutions; such as QMS to streamline quality workstreams and CAPA management.
• Support/lead as required on administration of R&I incident investigation and management, ensuring learning is shared and actions followed up appropriately.
• Provide support in the preparation, facilitation of external audits /inspections/accreditation visit conducted within the programme.
• CAPAs tracking and completion of actions following incidents, audits, changes in practice etc.
• To assist teams in the review of documents and completion of audits as required by regulatory standards.
• Prepare documents and agendas for governance and operational meetings.
• Communicate with a wide range of internal and external stakeholders regarding quality improvement.
• Requiring sensitive negotiation where necessary to ensure improvements are built into service delivery and are demonstrated in clinical outcomes.
• To attend regular and ad hoc meetings as required.
• Contribute to the development of quality improvement plans and lead on quality improvement audits/projects as required.
• Work collaboratively with the Research Quality and Regulatory Compliance Manager to assist with the identification and meeting of quality objectives as set out by the annual quality report.
• Contribute to Divisional and Trust's quality agenda in promoting a culture of continuous improvement.
• In collaboration with the Research Quality and Regulatory Compliance Manager recognise and act upon departures from legislative, quality management system requirements including failure to follow protocols and/or SOPs and incidents, errors or adverse events responding appropriately and escalating action as required.
• Work in accordance with the Divisional standards for document control and change control providing support for the operational implementation of such processes as required.

Information Management

• Maintain precise and accurate quality management records that are ready for inspection by regulatory authorities/accreditation bodies and Sponsor.
• Provide regular and ad hoc reports as required
• Assist in ensuring that business continuity arrangements are in place and updated in the event of any disruptions to electronic systems
• Update and Maintain databases relating to the Quality Management Framework.
• Interact with Trust reporting systems - DCIQ, and other relevant reporting systems to evaluate quality findings.
• Support the Research Quality and Regulatory Compliance Manager in the analysis of intelligence to assess to the effectiveness of the Quality Management System and to contribute to validation exercises of new computerised systems in use within R&I setting.
• Ensure that all paper-based/electronic systems are maintained securely.

Continuing Professional Development and Education

• Take responsibility for self-development through the appraisal system and work towards completing agreed personal development plan
• Develop new skills and knowledge pertaining to the speciality as required and attend relevant training / study days.
• Maintain and update knowledge of related regulatory and other relevant standards including ICH-GCP, UK Policy Framework for Health and Social Care Research, Medicines for Human Use (Clinical Trials) (Amendment) Regulations and UK Data privacy legislation.
• Provide training to staff in the use electronic quality management systems/ control systems software applications

Person specification

Qualifications

Essential criteria

• Educated to degree level or equivalent specialised professional knowledge
• Evidence of continuing professional development
• Current GCP Certificate

Desirable criteria

• Post graduate qualification

Experience

Essential criteria

• Risk management administration
• Previous experience of audit and follow up actions.
• Experience of collating, using, analysing and presenting data.
• Experience of working with incident/issue management framework

Desirable criteria

• Quality Improvement experience

Skills

Essential criteria

• Able to problem solve and initiate change.
• Able to work across professional teams and organisational boundaries.
• Good organisational skills with the ability to problem solve/negotiate.
• Ability to prioritise against tight deadlines.
• Excellent verbal, reporting and presentation skills.
• Good interpersonal and communication skills, with the ability to establish and maintain effective working relationships.
• Able to influence, even within a complex and challenging environment.
• Excellent IT skills including intermediate Microsoft Excel skills.
• Ability to provide reasoned advice and support.
• Ability to evaluate evidence and make reasoned independent decisions.
• Demonstrable ability to develop and maintain effective partnership arrangements both internal and external to the service.

Knowledge

Essential criteria

• An understanding of the principles of quality management systems.
• Knowledge of clinical research standards and regulations.

Desirable criteria

• Human Tissue Standards.

Values

Essential criteria

• Ability to demonstrate the organisational values and behaviours.

Other

Essential criteria

• A flexible approach to work.
• Willing to support others.
• Effective time management.
• Confident in willing to challenge traditional assumptions and provide evidence to support change and drive forward improved ways of working.
• Takes responsibility for own actions and promotes good team working.
• Shares information and good practice appropriately.

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