Summary
The post holder will have an extensive understanding of clinical safety and will be responsible for efficient and effective management of Digital Clinical Safety on behalf of the organisation. The role is responsible for providing leadership, guidance, support and specialist knowledge and clinical safety review and approval for the lifecycle of new digital solutions and upgrades to existing digital solutions. This includes the assessment of clinical safety issues at all points in the procurement, manufacturing, integration, implementation and decommissioning of software and hardware, including on-going clinical risk management once transferred to live service and ensuring all digital solutions conform to relevant national standards for clinical safety.
As a Registered Health and Care Professional reporting to the executive the Head of Clinical Safety will provide oversight of clinical safety incidents to ensure swift resolution and that any lessons learnt feed into service improvement.
The Head of Clinical Safety will be seen as a leading authority and primary point of contact for all matters relating to clinical safety of digital health systems. The postholder will be responsible for the identification, assessment and mitigation of direct and indirect clinical hazards to patients.
Work Activity Components
| Title | Details |
|---|---|
| Advice and guidance (SFAS) (Level 6) | Provides advice and guidance on the clinical risk management of regulated and unregulated software to digital teams, highlighting non-compliance with standards and agreeing appropriate actions to address them. |
| Analysis review (SFAS) (Level 6) | Assesses clinical risk management outputs included within the risk management file by others. Takes responsibility for quality assurance of all clinical risk management activities. |
| Assessment reporting (SFAS) (Level 6) | Liaises with the leadership to provide clinical risk assessment findings including face-to-face discussion and written feedback. Produces clinical risk assessment reports to agreed standards, including written outputs and verbal feedback. Reviews and approves clinical risk assessment reports written by others. |
| Business needs (Level 6) (ITSP) | Has a clear and thorough understanding of the needs of the business and uses this to develop strategy and plans. Focuses on business risk and continuity issues which impact the strategy. Takes full advantage of wider issues, e.g. commercials, people, processes and systems, for any proposed IT strategy. Understands current IT estate and operations, as well as current enterprise architecture objectives and constraints. |
| Career paths and mentoring (PEMT) (Level 5) | Advises individuals on career paths, and encourages pro-active development of skills and capabilities. Provides mentoring to support professional development. |
| Communication (Level 6) (ITSP) | Communicates the strategy and plan as appropriate through-out the organisation, adjusting according to stakeholder needs. Influences across the organisation to ensure its successful adoption and implementation. |
| Complex projects (SFEN) (Level 6) | Manages clinical risk activities for digital health products of any scale, adapting the clinical risk management system to match the complexity of the solution. Provides leadership, guidance and expert advice to ensure safe delivery in complex or high-risk environments. |
| Develops and builds effective relationships (RLMT) (Level 6) | Develops and maintains collaborative relationships with frontline staff and managers to support shared understanding of clinical risk and patient safety in the deployment and use of digital health technologies. |
| Empowerment and role model(PEMT) (Level 5) | Facilitates effective working relationships within and between teams of staff. Motivates groups of staff and teams towards a high level of performance. Engages with, and empowers groups of staff. Acts as a role model for groups of staff, setting a standard, acting professionally at all times and working to a professional code of conduct and ethics. |
| Engagement (ITSP) (Level 6) | Gains authority in the organisation, including from the wider leadership community. Influences stakeholder groups as required to successfully gain their support and commitment. |
| Good practice (ISCO) (Level 7) | Maintains detailed awareness of, takes fully into account as necessary, and promotes throughout the organisation, any relevant statutory, internal, or external regulations, standards, and codes of good practice, e.g. those relating to security, cyber security quality, data protection, audit etc. Is a major contributor to the definition of such regulations, standards and codes. |
| Guidance (BURM) (Level 6) | Provides clinical safety leadership across the organisation, guiding the development and implementation of clinical risk management strategies. Advises on the design and operation of the organisation-wide clinical risk management system. |
| Guidance, performance and feedback (PEMT)(Level 4) | Provides direction, support and guidance as necessary, in line with individual's skills and abilities and role expectations. Sets achievable goals, monitors and acknowledges performance. Makes learning recommendations to support individual and team development. Collects data on individual and team performance. Gives regular feedback to team members and leads them to achieve their full potential. |
| Hazard/risk assessment (SFEN) (Level 6) | Leads and takes full responsibility for clinical safety hazard analysis and risk assessment on systems. |
| Implementation and resources (BURM) (Level 6) | Plans and manages the implementation of organisation-wide processes and procedures, tools and techniques for the identification, assessment, and management of clinical risk inherent in the operation of processes and of potential risks arising from planned IT-enabled change. |
| Incident management (USUP) (Level 4) | Supports investigations into clinical safety incidents, ensuring mitigation measures are implemented to make safe and minimise future risk. Analyses and reports on clinical safety incidents to senior leadership and updates hazard logs and safety cases as necessary. |
| Leadership(ITSP) (Level 6) | Leads the strategic planning process. Seeks and gains senior stakeholder involvement and support into the strategic planning process to deliver measurable business value. |
| Monitoring (ITSP) (Level 6) | Regularly monitors and reviews progress on the strategy and plan, communicating, updating and evolving as required with the necessary senior stakeholder support. |
| Strategy planning (ITSP) (Level 6) | Builds a robust high-level plan to deliver the strategy. Is aware of the budgetary and other constraints in analysing business proposals and delivering the plan successfully. |
| Representation (ISCO) (Level 7) | Represents IT issues, on behalf of the entire organisation, with the highest management and external bodies, e.g. negotiating volume discounts with suppliers. |
| Strategy communication (ISCO) (Level 7) | Establishes, maintains and communicates the organisation's strategy for managing information, and the policies, standards, procedures and methods necessary to implement the strategy. |
| Vision (ISCO) (Level 7) | Maintains an awareness of the global needs of the whole enterprise, and promotes the vision of the benefits that a common approach to IT will bring to the business as a whole amongst senior executives. |
| Patient safety risk (BURM) (Level 6) | Appraises patient safety risk in the procurement, design, development, deployment and decommissioning of information systems and technologies and ensures that all risk is assessed and managed appropriately to minimise or avoid harm. |
| Risk management (BURM) (Level 6) | Plans and manages the implementation of organisation-wide processes and procedures, tools and techniques for clinical risk management associated with digital systems. Manages clinical safety risk assessment activities within the organisation. Develops clinical risk management processes and procedures, and identifies and deploys appropriate tools and techniques (e.g. SWIFT, FMEA). |
| Risk management of software as a medical device (BURM) (Level 6) | Assesses software products to determine whether they meet the criteria for classification as Software as a Medical Device (SaMD). Conducts hazard identification and risk assessments in accordance with ISO 14971. Produces and maintains documentation to demonstrate compliance with the UK Medical Device Regulation (MDR), including the creation and maintenance of the Risk Management File and supports the regulatory lead in the production and ongoing integrity of the technical file and Quality Management System. Manages updates to documentation and safety cases throughout the device lifecycle, ensuring post-market surveillance, incident reporting and change control processes are embedded to maintain ongoing regulatory compliance. |
| Risk strategy, processes and monitoring (BURM) (Level Six) | Identifies and categorises organisation-wide strategic and operational risks. Breaks down risks by sub-categories, such as compliance, architecture, environment, financial etc. and considers mitigation activities in the context of organisational risk appetite. |
| System development standards (DLMG) (Level 6) | Sets the clinical risk management system and drives adherence for standards for systems development projects, whether predictive (plan-driven) approaches or more adaptive (iterative/agile) approaches. |
| Safety assurance/compliance (SFEN) (Level 6) | Captures, evaluates and specifies clinical safety requirements for digital systems, ensuring they are proportionate to the level of risk and appropriate to the system’s intended use. |
| Standards/methods/tools (SFEN) (Level 6) | Champions the NHS safety standards (DCB0129/0160), methods and tools and ensures that they are applied effectively. |
| Review planning (SFAS) (Level 6) | Approves the Clinical Risk Management Plan and aligns this with the organisational Clinical Risk Management System, where required can advise on alignment with project plans and wider governance requirements. |
| Service development (Level 6) (ITMG) | Engages with and influences senior level stakeholders and project teams throughout the service development lifecycle. Ensures that clinical safety requirements are embedded into design and new or changed digital health technologies are managed to provide agreed levels of clinical safety. |
| Service improvement (Level 6) (ITMG) | Identifies opportunities to enhance clinical safety through service improvements and aligns the contribution of systems and services to clearly stated clinical safety targets. |
| Technology strategy (Level 6) (ITMG) | Provides technical and operational input to the development of the technology strategy to support the effective implementation of clinical safety. |
| Work allocation, support and delegation (PEMT) (Level 5) | Allocates responsibilities, including supervisory and assigns packages of work to groups of staff. Ensures that work packages are aligned with the particular skills and abilities of teams. Supports teams in the delivery of work packages. Delegates work to individuals and teams, taking full account of skills and capabilities. |
| Empowerment and role model(PEMT) (Level 5) | Facilitates effective working relationships within and between teams of staff. Motivates groups of staff and teams towards a high level of performance. Engages with, and empowers groups of staff. Acts as a role model for groups of staff, setting a standard, acting professionally at all times and working to a professional code of conduct and ethics. |
| Stakeholder engagement (RLMT) (Level 6) | Communicates with internal and external stakeholders to convey clinically relevant information relating to digital health systems, particularly where changes are complex, sensitive, or contentious. Applies advanced communication and interpersonal skills to ensure clear articulation of clinical safety risks, negotiates appropriate mitigations, and influences decision-making across diverse stakeholder groups and seniority levels. |
Behavioural Skills
| Title | Details |
|---|---|
| Analytical Thinking | Acquiring a proper understanding of a problem or situation by breaking it down systematically into its component parts and identifying the relationships between these parts. Selecting the appropriate method/tool to resolve the problem and reflecting critically on the result, so that what is learnt is identified and assimilated. |
| Attention to Detail | Applying specific quality standards to all tasks undertaken to ensure that deliverables are accurate and complete. |
| Conceptual Thinking | Acquiring understanding and insights regarding the underlying issues in complex problems or situations through the development of abstract representations, the identification of patterns and the analysis of hypotheses. |
| Counselling and Developing Others | Helping others to understand their values, needs, goals and limitations and coaching them to develop their effectiveness towards the limits of their potential. |
| Critical Thinking | The ability to think clearly and rationally; review and evaluation of processes and outputs; the ability to engage in reflective and independent thinking; reasoned thinking involving critique. |
| Customer Focus | Understanding the needs of the internal or external customer and keeping these in mind when taking actions or making decisions. |
| Decision Making | Making decisions at the appropriate time, taking into account the needs of the situation, priorities, constraints, known risks, and the availability of necessary information and resources. |
| Delegation | Delegating tasks, responsibilities and authorities effectively. |
| Follow-up and Monitoring | Checking progress against targets, taking action to resolve exceptions/ issues and reporting and escalating where necessary. |
| Goal Orientation | Maintaining focus on agreed objectives and deliverables. |
| Holistic Thinking | The ability to place problems in the context of the wider business landscape or area of interest. Understanding how different business functions work together to achieve shared goals. |
| Influence, Persuasion and Personal Impact | Conveying a level of confidence and professionalism when engaging with stakeholders, influencing positively and persuading others to take a specific course of action when not in a position of authority. |
| Interacting with People | Establishing relationships, contributing to an open culture and maintaining contacts with people from a variety of backgrounds and disciplines. Effective, approachable and sensitive communicator in different communities and cultures. Ability to adapt style and approach to meet the needs of different audiences. |
| Leadership | Clearly articulating goals and objectives, and motivating and leading others towards their achievement. |
| Organisational Awareness | Understanding the hierarchy and culture of own, customer, supplier and partner organisations and being able to identify the decision makers and influencers. |
| Planning and Organisation | Determining a course of action by breaking it down into smaller steps and by planning and resourcing each of these, making allowance for potential problems and escalating if necessary. |
| Providing Direction | Directing others to undertake specified tasks within a defined timescale. |
| Strategic Perspective | Keeping organisational objectives and strategies in mind, and ensuring courses of action are aligned with the strategic context. |
| Strategic Thinking | Long-term, broad vision perspective, situational analysis and pattern identification to anticipate potential outcomes when considering immediate and future implications of actions and decisions. |
Technical Skills
| Title | Details | Depth |
|---|---|---|
| Big Data | The discipline associated with data sets so large and/or complex that traditional data processing applications are inadequate. The data files may include structured, unstructured and/or semi-structured data, such as unstructured text, audio, video, etc. Challenges include analysis, capture, curation, search, sharing, storage, transfer, manipulation, analysis, visualization and information privacy. | Familiar with |
| Business Continuity Planning | Methods and techniques for risk assessment, business impact analysis, establishment of countermeasures and contingency arrangements relating to the serious disruption of IT services. | Proficient in |
| Clinical Risk Management | The planning and management of clinical safety activities across the lifecycle phases for safety related system developments. | Familiar with |
| Clinical Safety Engineering | Methods and techniques for safety engineering during all clinical safety lifecycle phases for system developments. | Familiar with |
| Clinical Safety Related Application Development Techniques | Methods and techniques for developing clinical safety related and clinical safety critical applications. | Proficient in |
| Cloud/Virtualisation | The principles and application of cloud/ virtualisation (including ownership, responsibilities and security implications). Use of tools and systems to manage virtualised environments. | Familiar with |
| Corporate, Industry and Professional Standards | Applying relevant standards, practices, codes, and assessment and certification programmes to the specific organisation or business domain. | Proficient in |
| Incident Management Tools | Including interrogation of incident database, creation of parent and child incidents, creation of queries to seek trends and use of known error logs/ databases. | Familiar with |
| IT Environment | The IT environment relating to own sphere of work (own organisation and/or closely associated organisations, such as customers, suppliers, partners), in particular own organisation's technical platforms and those that interface to them through the specialism, including those in closely-related organisations. | Proficient in |
| National/International Standards | Current and emerging standards associated with IT practice nationally and internationally, published by authorities such as IEEE, IEC, BSI, ISO. | Proficient in |
| Own Organisation's IT Products and Services | The IT products and/or services supplied to internal and external customers by own organisation. | Proficient in |
| Principles of Clinical Safety Assurance | Methods and techniques for clinical safety assurance during all lifecycle phases of clinical safety related system developments. | Expert in |
| Software Testing | Testing techniques used to plan and execute software tests of all application components (functional and non-functional) to verify that the software satisfies specified requirements and to detect errors. | Familiar with |
| Software Testing Tools | Software tools which automate or assist any part of the testing process across all or part of the testing lifecycle. | Familiar with |
| Structured Reviews | Methods and techniques for structured reviews, including reviews of technical work products, test plans, business cases, architectures and any other key deliverables. | Proficient in |
Other Skills
| Title | Details | Depth |
|---|---|---|
| Appraisal Techniques | Methods and techniques for appraising an individual's performance and potential. | Proficient in |
| Artificial Intelligence Concepts | Understanding of concepts and trends in artificial intelligence and the potential benefits and real-world implications, including risk and security, of its deployment within the organisation. | Familiar with |
| Business Characteristics | Organisational structures; their mission, objectives, strategies and tactics adopted by organisations; measures of performance such as critical success factors and key performance indicators; organisational cultures and cultural dimensions. | Proficient in |
| Business Proposals | Methods and techniques for preparing and presenting business cases, requests for proposal (RFP) invitations to tender (ITT) and statements of requirements/work both verbally and in writing. | Proficient in |
| Coaching Techniques | Methods and techniques for coaching individuals or groups by a balanced combination of support and direction, which could include use of virtual learning environments plus add-ons to augment feedback specific to work items, workflow or career plans. | Proficient in |
| Disciplinary Issues and Procedures | Managing episodes of unsatisfactory behaviour or performance in accordance with appropriate policies and legislative conformance. Includes changes to circumstances, such as sickness, disability and other personal issues. | Familiar with |
| Due dilligence | The techniques and processes undertaken to conduct a comprehensive review, or audit, of a target investment or company prior to merger or an acquisition in order to support informed decision making and optimise business benefit. | Proficient in |
| Information Elicitation Techniques | The selection and application of information elicitation methods, tools and techniques that are appropriate to the information required and the sources available. | Proficient in |
| Legislation | Relevant national and international legislation. | Expert in |
| Performance Monitoring | Identifying, agreeing and monitoring (usually by face-to-face interviews) objectives and deliverables with individuals. Identifying under-performance issues against agreed quality standards and performance criteria. Identifying gaps in capability and causes, disciplinary or ability-related (needing assistance, training or other support). | Proficient in |
| Presentation Techniques | Methods and techniques for delivering effective and accessible presentations, either face-to-face or online within various contexts and to a variety of audiences. | Proficient in |
| Process Improvement Techniques | Methods, tools and techniques to analyse and optimise processes in order to improve the quality of a product or service. | Proficient in |
| Project Planning and Control Techniques | Methods and techniques associated with planning and monitoring progress of projects. | Proficient in |
| Project Risk Management | The identification, assessment and management of project risks, that could result in time or cost over-runs, or failure to deliver products which are fit for purpose. | Expert in |
| Report Writing Techniques | Methods and techniques for writing clear, accessible and persuasive reports. | Proficient in |
| Resource Allocation | The effective and efficient routine deployment of resources, (but also including reassessment and reallocation in a dynamic multi-project environment), to achieve optimum results. | Proficient in |
| Risk Management | Methods and techniques for the assessment and management of business risk. | Expert in |
| Stakeholder Engagement | Establishing relationships, analysing perspectives and managing stakeholders from a variety of backgrounds and disciplines. Adapting stakeholder engagement style to meet the needs of different audiences. The identification of key business stakeholders and an assessment of their level of power and interests, and their perspectives to inform the way(s) in which they should be considered and managed. | Expert in |
| Team Dynamics | Knowledge and understanding of the psychological and environmental forces that influence the direction of team behavior and performance and the tools and techniques to improve team cohesion and performance. | Familiar with |
| Techniques for Effective Meetings | Methods and techniques for running effective meetings and for understanding and influencing the roles played by participants. | Proficient in |
Training
| Title | Details |
|---|---|
| Advanced Techniques for Business Process Improvement | More complex tools and techniques associated with the analysis, modelling and streamlining of business processes. |
| Coaching | Concepts, methods and techniques for providing coaching in subject specialisms to individuals or groups (e.g. GROW model). |
| Diversity and Inclusion | Raise diversity in-the-workplace awareness in order to better understand how the world looks through the eyes of people of a different age, race, gender, sexuality, etc, improve communications with people from diverse backgrounds and reduce the levels of unconscious bias in decision-making. |
| Human Resource Planning | Techniques and practices involved in planning the numbers and types of personnel needed over time by a particular skillset, department or function within an organisation. |
| Latest Cyber Security Threats for Senior Execs | Short, high-level, up-to-date and to-the-point briefing on the latest threats and vulnerabilities in cyber security. |
| Quality Assurance Auditing | The quality audit process; different types of audit and their application; techniques used for planning, executing, reporting and following-up audits. |
| Risk Management Methods, Techniques and Tools | Methods, techniques and tools for the analysis, assessment and management of risk. |
| Software Quality Assurance Techniques | Methods, techniques and standards for the quality assurance of the software development process. |
| Standards Creation, Implementation and Monitoring | Methods and procedures for creating, disseminating and monitoring the use of standards relevant to the development and deployment of IT services. |
| Strategic Planning for Information and Communications Systems | The process of defining the ICT strategic plan of an organisation in a methodical way based on business aims and objectives thereby enabling the specification of options and associated action plans for the use of IT-enabled business processes. |
Professional Development Activity (PDA)
| Title | Details | PDA Group |
|---|---|---|
| Gaining Knowledge of Broader IT Issues | Increasing and maintaining currency of knowledge of broader IT issues through reading, attending and participating in seminars or conferences, special studies, temporary assignments etc. | Increasing Knowledge |
| Gaining Knowledge of Standards and Legislation | Gaining and maintaining knowledge of relevant national and international standards and legislation. | Increasing Knowledge |
| Gaining Strategic Knowledge of Employing Organisation | Developing a comprehensive understanding of the business environment in which the employing organisation operates and its position, policies and direction in relation to health and care, country and global issues. | Increasing Knowledge |
| Job Shadowing and Special Assignments | Undertaking temporary periods or secondments in other roles, particularly those that offer a new perspective on own function or exposure to other environments and cultures. | Broadening Activities |
| Management Development | Undertaking learning and best practice of the skills appropriate to managing all or part of an organisation, including business and financial management, benefits management, people management, management of change and strategic planning. This will require both on and off the job learning and may include participation in an appropriate development programme such as MBA or DMS (Diploma in Management Studies). | Developing Professional Skills |
| Mentoring | Acting as a mentor, advising those for whom there is no direct responsibility, on matters to do with their job role, career and professional development. | Broadening Activities |
| Participation in Professional Body Affairs | Taking an active part in professional body affairs at branch, specialist group, committee or board level. | Participation in Professional Activities |
Qualification Components
| Title | Awarding Bodies |
|---|---|
| FEDIP Leading Practitioner | The Federation for Informatics Professionals |
The Professional Body Responsible for this job family is BCS. This job role profile was created in collaboration with BCS, using Role Model Plus.