The 4 Nations NHS/HSC Compatibility Programme is a significant strategic UK change programme. This high profile programme of work aims to improve the flow and productivity of systems that support the set up and delivery of health and social care research across the UK.Each UK nation has created an Operational Lead function to:● Align existing activity to the 4 Nations NHS/HSC Compatibility Programme.● Bring strategic focus and structure, alongside operational knowledge, to the… Show more The 4 Nations NHS/HSC Compatibility Programme is a significant strategic UK change programme. This high profile programme of work aims to improve the flow and productivity of systems that support the set up and delivery of health and social care research across the UK.Each UK nation has created an Operational Lead function to:● Align existing activity to the 4 Nations NHS/HSC Compatibility Programme.● Bring strategic focus and structure, alongside operational knowledge, to the programme’s initiatives.● Ensure alignment of work with the programme’s overall strategic objectives, both as a nation and across the UK.● Consider and articulate the potential impact of decisions and widespread consequences of those decisions on NHS/HSC service enhancement and sustainability.As part of this programme, I am responsible for:● Leading the operational programme management, governance and reporting of the Programme within nation.● Setting, with others, the direction of travel of the Programme in nation ensuring that it builds on and adds value to both the work and engagement of earlier work.● Ensuring the Programme’s direction of travel aligns to and actively supports the delivery of national transformation projects.● Managing stakeholder change resistance, with others, including UK and international commercial/non commercial organisations, approval bodies, networks and policy makers.● Acting as a conduit between policy makers and operational delivery staff, applying specialised skills and knowledge to advise policy makers.● Staying abreast of wider developments in nation, the NHS and internationally, and use that business intelligence in realising the full potential and objectives of the Programme.● Distilling varied and highly complex information and concepts into easily understood systems and processes to support the implementation of changes.● Fulfil an ambassadorial role in representing Wales at a number of UK strategy and operational boards. Show less

The Permissions Service coordinates the process of gaining research permissions from NHS (National Health Service) organisations across Wales. The service is part of the Health and Care Research Wales infrastructure [www.healthandcareresearch.gov.wales], commissioned, funded and managed by Welsh Government’s Division for Social Care and Health Research. The Health and Care Research Wales Support & Delivery Centre is hosted by Powys Teaching Health Board [www.powysthb.wales.nhs.uk].I… Show more The Permissions Service coordinates the process of gaining research permissions from NHS (National Health Service) organisations across Wales. The service is part of the Health and Care Research Wales infrastructure [www.healthandcareresearch.gov.wales], commissioned, funded and managed by Welsh Government’s Division for Social Care and Health Research. The Health and Care Research Wales Support & Delivery Centre is hosted by Powys Teaching Health Board [www.powysthb.wales.nhs.uk].I was responsible for:● Leading the development and oversaw the implementation of what became the Permissions Service, with 96% of research studies receiving NHS permission within 40 calendar days and 510 studies open and recruiting in Wales during 2017-18. ● Leading, developing, implementing and improving processes with a high level of complexity including processes that ensure research studies meet regulatory and legal standards. ● Participating in and/or leading special projects and initiatives requested by executive management.● Interacting with and influencing stakeholders on process change and improvement, for example, through the membership of operational steering groups and change management boards.● Leading quality management review of key process areas to identify emerging trends and areas of high impact, communicating lessons learned and areas for improvement. Ensuring the evaluation responses to quality management and that any agreed revisions were incorporated into reviews and/or processes. Identifying, sharing and interpreting revisions to regulatory and legal requirements and guidelines.● Leading the development and reporting of key service related metrics; presenting on risks, issues, initiatives and projects at cross function meetings.● Providing guidance and expert evaluation of policies, frameworks and guidance with oversight of any significant issues identified, driving process improvement ensuring changes and solutions were implemented and effective. Show less

The Permissions Coordinating Unit coordinated the process of gaining research permissions from NHS organisations across Wales. The unit was part of the NISCHR (National Institute for Social Care and Health Research) AHSC (Academic Health Science Collaboration) who facilitated collaboration to combine clinical research, both basic and translational research, clinical care and education to create world-leading improvements in healthcare. Powys Teaching Health Board [www.powysthb.wales.nhs.uk]… Show more The Permissions Coordinating Unit coordinated the process of gaining research permissions from NHS organisations across Wales. The unit was part of the NISCHR (National Institute for Social Care and Health Research) AHSC (Academic Health Science Collaboration) who facilitated collaboration to combine clinical research, both basic and translational research, clinical care and education to create world-leading improvements in healthcare. Powys Teaching Health Board [www.powysthb.wales.nhs.uk] hosted the NISCHR AHSC.I was responsible for the delivery of the research permissions service and managing the Permissions Coordinating Unit, in particular:● to develop, implement and deliver consistent and standardised processes from concept to operational business,● to build and maintain effective and collaborative working relationships with the NHS organisations of Wales and other key stakeholders,● to formulate and direct both the strategic and operational plans of the research permissions service, ensuring a broad range of complex activities are progressed to achieve milestones and where necessary implement corrective actions to ensure the completion of the activities, and● to provide leadership to unit staff member to ensure that the team’s capacity, experience and knowledge are optimal for the governance review of research studies through the research permissions service. Show less

The All Wales Primary Care RMG (Research Management & Governance) Office coordinated the process of gaining research permission for healthcare research studies to be conducted in, or recruit participants from, a primary care setting across Wales. Powys Teaching Health Board [www.powysthb.wales.nhs.uk] hosted the All Wales Primary Care RMG office.I established the office under the under the direction of the Welsh Government leads for Healthcare Research and Development (R&D). I was… Show more The All Wales Primary Care RMG (Research Management & Governance) Office coordinated the process of gaining research permission for healthcare research studies to be conducted in, or recruit participants from, a primary care setting across Wales. Powys Teaching Health Board [www.powysthb.wales.nhs.uk] hosted the All Wales Primary Care RMG office.I established the office under the under the direction of the Welsh Government leads for Healthcare Research and Development (R&D). I was responsible for developing and implementing a research governance review service for primary care and managing the office, in particular:● to formulate and implement a research governance process that would provide a standard and consistent review or healthcare research studies to be conducted in, or recruit participants from, a primary care setting across Wales,● to work with the Local Health Boards of Wales in delivering the research governance service,● to ensure that adequate training and guidance was given to those involved in delivering the service, and● to provide effective communications channels for sharing knowledge and best practices. Show less

The WCTU (Wales Cancer Trials Unit) is a clinical trials unit providing management and coordination of high quality research studies on new cancer medicines and treatments including chemotherapy, radiotherapy and surgery.As Quality Assurance (QA) Manager, I was responsible for ensuring the unit’s compliance with all research related regulatory frameworks and legislation. I was responsible for creating, progressing and supervising the implementation of a regulatory inspection ready… Show more The WCTU (Wales Cancer Trials Unit) is a clinical trials unit providing management and coordination of high quality research studies on new cancer medicines and treatments including chemotherapy, radiotherapy and surgery.As Quality Assurance (QA) Manager, I was responsible for ensuring the unit’s compliance with all research related regulatory frameworks and legislation. I was responsible for creating, progressing and supervising the implementation of a regulatory inspection ready Quality Management and Audit system.I set-up and developed the Quality Assurance (QA) function within the unit, and was responsible:● for providing professional expertise on all matters relating to quality assurance and taking the leadership role for the quality assurance strategy of the unit,● for leading and developing the quality assurance team, quality management systems as well as the quality policies, standard operating procedures/work instructions, corrective and preventive action (CAPA) plans, and ● for developing and coordinating the unit pharmacovigilance system taking into account the requirements of EurdaVigilance and the MedDRA (Medical Dictionary of Regulatory Activities). Show less

Simbec Research Ltd. is one of Europe’s leading contract research organisations providing services to both the European and Global pharmaceutical industry. They specialise in Phase I/ IIa clinical studies, bioequivalence, and bioanalysis – pre-clinical to Phase IV.As Project Manager (PM), I was accountable for the successful completion of an assigned research study portfolio from protocol design through to study report and archiving. I was responsible:● for the completion of… Show more Simbec Research Ltd. is one of Europe’s leading contract research organisations providing services to both the European and Global pharmaceutical industry. They specialise in Phase I/ IIa clinical studies, bioequivalence, and bioanalysis – pre-clinical to Phase IV.As Project Manager (PM), I was accountable for the successful completion of an assigned research study portfolio from protocol design through to study report and archiving. I was responsible:● for the completion of research studies where success was the delivery of a study on-time, on-budget with high quality regulatory compliant study results that led to satisfied clients receiving a quality project management service,● for ensuring effective communication with the study teams and clients through study status and progress reports, and ● for acting as a client’s representative in preparing, submitting and defending applications to regulatory and ethical review bodies acting as the main point of contact for these review bodies. Show less

● Completed Doctor of Philosophy (PhD), Biosciences (Clinical Research) at Cardiff University. Admitted to the degree Doctor of Philosophy on 30 July 2004.● ThesisCotterill-Jones C. (2003). The effect of placebo treatment on cough and the immune response. PhD thesis, Cardiff University, Cardiff.● Publication:Lee PC, Cotterill-Jones C, Eccles R. Voluntary control of cough. Pulm Pharmacol Ther. 2002;15(3):317-20. [PMID:12099785[PubMed - indexed for MEDLINE]]

Intercern was a UK based hospital SMO (Site Management Organisation) offering research site management and research participant/ patient recruitment services at over 70 hospital and primary care sites.As Site Facilitator at research sites in South Wales, I was responsible:● for assessing potential research sites and research participant/ patient populations against research protocol requirements,● for preparing, submitting and defending applications made to Research Ethics… Show more Intercern was a UK based hospital SMO (Site Management Organisation) offering research site management and research participant/ patient recruitment services at over 70 hospital and primary care sites.As Site Facilitator at research sites in South Wales, I was responsible:● for assessing potential research sites and research participant/ patient populations against research protocol requirements,● for preparing, submitting and defending applications made to Research Ethics Committees (RECs), and● for offering full research site support throughout the research study by advising on study management, recruitment strategies and sharing best working practices from research sites across the Intercern network. Show less

DHP Limited specialised in the preparation, packaging and distribution of Investigational Medicinal Products and Clinical Trial Supplies for research studies – phases I through IV.I was responsible for identifying the company’s target customers and identifying methods of promoting the company’s services to these customer groups, in particular:● for researching current market trends and studying competitor marketing strategies,● for reviewing and developing market and business… Show more DHP Limited specialised in the preparation, packaging and distribution of Investigational Medicinal Products and Clinical Trial Supplies for research studies – phases I through IV.I was responsible for identifying the company’s target customers and identifying methods of promoting the company’s services to these customer groups, in particular:● for researching current market trends and studying competitor marketing strategies,● for reviewing and developing market and business plans for the company’s clinical trial packaging and supply, and ● for developing tailored clinical trial supply, packaging and distribution solutions, that met customer needs. Show less

● Returned to De Montfort University to complete Bachelor of Science (BSc) Pharmaceutical & Cosmetic Sciences degree after a work placement year at the Common Cold Centre, Cardiff University.

The Common Cold Centre is a university-based centre of excellence devoted to the development of new treatments for coughs, colds and hay fever.For my degree placement, I was a laboratory technician at the centre responsible:● for recruiting and assessing potential participant who volunteered to take part in the clinical research studies,● for explaining the use of specialised research study equipment and performing research study procedures, and ● for maintaining study data… Show more The Common Cold Centre is a university-based centre of excellence devoted to the development of new treatments for coughs, colds and hay fever.For my degree placement, I was a laboratory technician at the centre responsible:● for recruiting and assessing potential participant who volunteered to take part in the clinical research studies,● for explaining the use of specialised research study equipment and performing research study procedures, and ● for maintaining study data and completing research study records and case report forms. Show less