CTU DMEG

I am currently a CORE eCRF Data Analyst at the Clinical Informatics Research Unit, part of the University of Southampton, whilst also studying for an MSc in Public Health & Nutrition.  The CORE team delivers high-quality data services to clinical research teams within the UK and internationally; this includes but is not limited to eCRF database development, expert advice in all things data, and further support such as data management or validation.  I have accumulated previous experience in academic research working at Southampton Clinical Trials Unit as a Clinical Data Coordinator, and a strong understanding of clinical research due to my BSc in Biomedical Sciences.

I am very driven to contribute to the fast-paced world of research and recognise the incredible potential for academic organisations to hold a strong position on this stage.  I hope to bring my previous experience, as well as enthusiasm to learn from others in this sector, in order to explore avenues in which we can further improve the experience and standing of CTU’s in data management.

A highly skilled leader with extensive Clinical Data Systems and Data Management experience from working in a large and mid-sized Contract Research Organisations, Pharmaceutical company, and academic Clinical Trials Unit. Decisive and proficient in leadership and management, including building, coaching, and motivating teams; with a professional and calm approach in times of pressure. Extensive project management of large multi-national and small studies, across a wide range of therapeutic areas and clinical phases; demonstrating good internal and international collaborative approaches whilst adhering to ICH and GCP Guidelines. 

Experience of introduction of new systems and systems migration with stakeholders nationally and globally, with consideration for Business Continuity, Information governance, IT Security, Audit and Quality management.

Former Chair of the UK CRC Information Systems Operational Group.

Steph Foster is the Clinical Trial Data Management Specialist at the Institute of Cancer Research – Clinical Trials & Statistics Unit (ICR-CTSU).  The ICR-CTSU leads high-quality international cancer clinical trials, whose findings directly influence clinical practice within the NHS and worldwide. She is responsible for oversight of all aspects of clinical data management within the ICR-CTSU and management of the Clinical Data Science team using extensive leadership and project management experience gained over 20+ years working in large Contract Research Organisations/Pharmaceutical companies across all phases and many therapeutic areas.

Amanda has over 20 years experience managing the data management aspects of MHRA regulated drugs trials. As Head of Data Management within the CTRU, Amanda is responsible for the management of the data management group and oversight of data management on CTRU studies. She has been the Information Governance manager for ScHARR since 2016, responsible for the day-to-day operational management of research information governance activities within the School. Previously, Amanda worked for 11 years at PAREXEL International, progressing to lead Data Manager on a wide variety of clinical trials across a variety of phases and indications, including large multi-centre, international drugs trials which involved Europe, the US and Japan. Amanda is also a chair of the UKCRC Data and Information Systems Operational Steering Groups (DISOG).

Lindsey has worked in clinical trials data management for over 15 years and is passionate about developing best practice standards in data management and central monitoring. She currently leads the Data Management Systems team at UCL’s MRC Clinical Trials Unit, which comprises around 20 systems programmers, data management specialists and business analysts, and provides bespoke programming solutions and data management support for trials, studies, and cross-study work at the unit, She founded the unit’s Central Monitoring Group in order to promote best practice in risk-based central monitoring, and has co-authored several publications around data management in platform trials and other central monitoring and data management-related subjects. Lindsey is Chair of the Association for Clinical Data Management (ACDM) CTU Data Management Expert Group and a member of the UKCRC Data Management and Information Systems Operational Group (DISOG).

I am a Data Manager at Newcastle University Clinical Trials Unit. I’ve worked in clinical research since 2013 and have worked in several data management roles in the NHS, University and Industry. I’ve worked on both late and early phase trials over a wide variety of disease areas using several different CDMSs.

I joined the ACDM along with the rest of our data management team in 2018 and am looking forward to taking a more active role as part of the CTU data management expert group.

I have been head of Data Management at Norwich CTU since 2016, having previously worked in a variety of IT and data management roles across varied organisations and sectors, including the NHS and Industry. I have particular interests in data protection and information governance.

I have been a member of the ACDM since 2016, and look forward to working as part of the CTU Data Management Expert Group. I also sit on the UKCRC Data and Information Systems Operational Group.

Previously in the role of Senior Clinical Trial Manager at Southampton Clinical Trials Unit providing expertise to design and deliver complex eCRFs over a wide variety of disease areas following implementation of a new EDC platform, Laura made the transition to a sponsor organisation as Lead Clinical Data Manager in 2022. Laura continues to provide expertise and guidance on clinical data management, driving good data culture and best practice on behalf of a global clinical research team including being a CDISC volunteer developing standards for use in studies of tobacco products.

Laura joined the ACDM in 2023 and was delighted to join the CTU DMEG with the motivation to provide insight into her opportunities post-CTU including how this could be provided in a CTU environment.

I am a Clinical Data Manager at Luxembourg Institute of Health. I’ve worked in clinical research since 2018. I have initially worked as a CTA in France and then started working as a Clinical data Manager in Luxembourg. I have mostly worked on early phase trials, pilot trials as well as cohort studies over a variety of disease areas by using different CDMSs.

I have recently joined the ACDM and I am looking forward to take part in the CTU data management expert group

Having focused for several years on clinical database design and validation I am now heading up Data Management team at Southampton Clinical Trials Unit supporting database builders, stats programmers and in-conduct data managers. My role also involves providing expertise on IS evaluation and implementation, data governance and data standardisation and curation.

I also hold a PhD in Clinical and Experimental Neuroscience which provided me experience of managing a long-term follow up studies, processing and curating data from diverse sources, sample processing, management and tracking, experimental design and basic bench science.

My key skills involve team leadership, project management, and problem solving. I’m passionate about fostering collaboration and knowledge exchange across interdisciplinary teams in in order to drive innovation and excellence in clinical data management.

John joined the Hull Health Trials Unit in 2018 as part of the senior management team tasked with establishing a new clinical trials unit based in Hull. He established the data management function (staff and systems) required to deliver large multi-centre clinical trials including regulated CTIMPs. The HHTU is now an established UKCRC registered unit.

John led the establishment of the University of Hull’s Data Safe Haven, which became operational in summer 2020. This realised a long-held ambition of the University to deliver a trusted research environment with the security and accreditations required to house and analyse sensitive national datasets. Delivered by the HHTU, this virtualised service is available to researchers across the University, with access from wherever they are working.

Prior to this John worked for 15 years at the Clinical Trials Research Unit at the University of Leeds where he held a range of data roles culminating in leading the software development team.

John holds an MSc in Information Systems and is a chair of the UK Clinical Research Collaboration (UKCRC) Data and Information Systems Operational Group.