A member of the TransCelerate Patient Experience Initiative, where we collaborate across the industry to develop tools that provide more effective ways to engage with patients and caregivers in the design and execution of clinical studies.

Strategic and innovative role that brings patient centricity to life by embedding the voice of the patient and site into R&D strategy and implementation.> Ensure that patients and sites insights are collected and considered for internal digital/non-digital product development and the selection of digital solutions for use on our clinical trials. > Collaborate across Clinical Operations, Digital Health, Data Science and AI, Commercial, Medical and Procurement to develop innovative ways to capture patient and site experiences during our clinical trials

Responsible for the day to day full coordination and management of an AstraZeneca programme of research that includes two prostate cancer CTIMPS and one non-CTIMP (a circulating tumour DNA study in early phase cancer trials). Responsibilities include:• Trial Set-up: Assisting the Chief Investigator with writing and development of the trial protocol and all other required documents for a multi-centre prostate cancer CTIMP. Preparation of all documents and applications for submission to Ethics, R&D and the MHRA, using IRAS. • Drug Supply: Organising IMP supply for a multi-site study using a CRO, which includes contract management, label design, drug order form review and negotiating with the financial sponsor. • External Site Set-up: Identifying suitable sites, liaising with PIs, assessing site feasibility and setting up sites. • Trial Management: Organising, chairing and minuting trial management group meetings, regularly liaising with trial teams to ensure protocol compliance and to resolve issues through creative problem solving, maintaining good communication streams with all trial personnel, regularly liaising with industry collaborator to discuss progress, maintaining the TMF and ensuring all trial documentation is accurate and up-to-date with SOPs, legislative requirements and GCP guidelines, preparing and submitting amendments to the sponsor, REC and MHRA and managing the trial budgets. I am the point of contact for contracted CROs.• Data Management: Working with the data programmers and statisticians to design and build trial specific CRFs (using XML) and databases (Macro) and identify and design appropriate randomisation systems. Preparation of the data management plan, database entry guidelines and CRF completion guidelines. • Preparation and submission of Trial Reports and newsletters, including annual progress reports, quarterly newsletters, safety reporting (SAEs and SUSARs) to the sponsor, REC and the MHRA and end of study reports.

Responsible for the coordination of the laboratory and clinical aspects of interventional and observational non-CTIMP trials in cardiac surgery. Responsibilities included:• Trial Set-up: Worked with the trial team (trial manager, CI, statistician and pharmacist) to write the protocol and prepare submission documents.• Management of external sites: Responsible for the management of a multi-centre trial. This involved providing the sites with the appropriate resources, SOPs and training and ensuring they recruited to agreed timelines and targets.• Monitoring and closing sites: Visited sites to carry out routine monitoring; assessing adherence to both GCP and the protocol. Closed down the sites, which involved site visits and site file and CRF query resolution.• Maintenance of trial documentation: TMF and CRF preparation and management. Preparation of non-substantial and substantial amendments for submission. • Data management: Worked closely with the Leicester Clinical Trials Unit, who were contracted to build the database and perform statistical analysis. This involved regular meetings with the data programmers, data managers and statisticians to discuss database and CRF design and the statistical analysis plan. • Patient recruitment and safety monitoring: Directly involved in patient recruitment, working with the research nurses to screen patient’s and obtain informed consent. Monitored safety of patients, reported Serious Adverse Event’s to the sponsor and ensured patient compliance with study protocol. • Management of local clinical research team: Organised sample collection (blood and urine) and processing, data collection and staff training. • Management of local clinical Laboratory team: Organised the laboratory team to perform analysis of clinical trial samples, created SOPs for laboratory and clinical activities and carried out routine and specialised laboratory analysis. Liaised and negotiated with sales representatives for laboratory supplies.

- Lead investigator on a project that investigated the molecular mechanisms underlying the improved clinical outcomes of obese individuals following major cardiac surgery (obesity paradox), using microarray technology and bioinformatics.- Carried out a number of molecular techniques to investigate the molecular mechanisms underlying the beneficial effects of washing and rejuvesol treatment of red blood cells, for the prevention of organ injury following blood transfusion. - Worked in collaboration with the cardiac surgery research team to undertake routine laboratory analysis for all clinical trials associated with the British Heart Foundation founded research program entitled “Prevention of acute kidney injury after cardiac surgery”.

- An industry-partnered PhD which involved the development and validation of an in vitro skeletal muscle model to determine the toxic effects of drugs and chemicals.-Mentor to Masters and undergraduate students, providing them with training, support and motivation. Also involved in the planning and day-to-day running of summer placement and Masters students' projects.- Experience of working within multidisciplinary research groups and in collaboration with industry, which involved regular meetings with industry colleaugues to share ideas and critically analyse work. - Industrial Placement at Syngenta: Spent time at the Syngenta site (Jealott’s Hill, Surrey) as part of the collaboration, where I developed a knowledge of various techniques (bioinformatics, histopathology) and the processes involved in taking a new compound from discovery phase to market.Research conferences presented at:•Society of Toxicology (SOT) annual conference, San Antonio, Texas (March, 2013). (Poster presentation). - In Vitro Toxicology Society (IVTS) annual conference (November, 2011, 2012). - Syngenta: Oral communications and poster presentations at Syngenta as part of annual ‘Product Safety open days’ (September 2010, 2011, 2012). - Postgraduate Seminar Half Day, University of Leicester. Oral communication (May, 2012) and poster presentation (May, 2013). - Festival of Postgraduates, University of Leicester (May, 2011) (Poster presentation) - Vitae Midlands Hub regional Poster Competition, Nottingham University (July, 2011).