Greater London, England, United Kingdom
A knowledgeable, highly organised and proactive clinical research professional with many years' experience in the NHS, academic sector, pharmaceutical industry and now engaged as an independent consultant; successfully changed careers from process chemistry/drug development to clinical research and quickly progressed to more senior roles. Have coordinated both site-led and sponsor-led activities and obtained an MSc in clinical research (UCL) whilst working. Asked by Barts Health NHS Trust, an employer of over 16000, to manage the now seminal RECOVERY trial for the Trust at 5 hospitals during the COVID-19 pandemic. After working as a successful consultant with three clients for 1.5 years, returned to academic research as a senior trials and project manager of a new medical device AI based study. Decided to retire from full time work in February 2025 however interested in smaller projects where I can make an impact with my expertise in clinical research management, document preparation and regulatory issues.
The AssistMS clinical trial is a large multi-centre (~1300 participants) study that is the centrepiece of AssistMS: research designed to identify the safety and benefit of icometrix’ AI software, icobrain ms, being rolled out across the NHS. Unless effectively treated, multiple sclerosis (MS) leads to significant disability and care costs in most cases. However, whether any of the currently licensed 15 disease modifying treatments (DMTs) is effective in an individual person with MS is unpredictable. Effective treatment monitoring is essential to (i) detect signs of disease activity and (ii) enable early switching to a different, hopefully (more) effective, DMT. In clinical practice, regular MRI is the only established tool for DMT efficacy monitoring. However, detecting the often subtle changes by inspecting MRI scans is time consuming, tiring and therefore error-prone. The study will assess the clinical usefulness, patient satisfaction and cost-effectiveness in routine care at three NHS Trusts. If successful, it is expected that the trial will provide evidence to support widespread adoption of icobrain ms across the NHS. I will take on lead responsibilities for the project. These will include: • Writing SOPs, essential documents, IRAS and aspects of the protocol. • Coordinate the project which includes a clinical audit that will inform the protocol and o installation of the icobridge software in PACS systems required to run the study • Train site staff in all aspects of the study • Work with an external vendor in CRF development as well as e-consent and e-PROs • Manage budget • Travel to sites and conduct monitoring visits • Prepare progress reports for the TMG, TSC, funder, sponsor, REC and HRA • Oversee the analyses, development of analysis plans and interim and final reporting as well as research reports/papers In addition, I will work with a team around preparing a business case for a Research Imaging Centre (RIC) proposal with Barts Life Sciences (BLS).
Freelance consultant with expertise in clinical research/trial management and as a CRA . I had three clients: 1. Was approached by a Multinational pharmaceutical firm to help them set up a burden of illness and health economic survey for patients with a rare hereditary metabolic disease. The regulatory issues are complex as many patients have diminished capacity and the survey also involves children therefore need to work closely with trial sites as well as address any HRA and REC concerns with vulnerable people. Part of team responsible for UK protocol, site budgeting, PIS/ICs and key document development (Sep 22-Sep 23) 2. Protocol writer and project manager working with a team to set up a medical device study involving MRI and AI-assisted scan interpretation. This will be a non-commercial multi-site cluster randomised study involving ~1300 participants. My role involves protocol writing, coordinating the team (CI, statistician, health economics, commercial (medical device provider co-leads) in pre-submission duties, negotiations with vendors, ensuring the trial's sponsor is informed of developments as well as starting regulatory paperwork (ie IRAS) (July 22-Sep 22) (Mar 23-Sep 23) 3. Contracted by an EU based CRO setting up and running UK trial sites for an international and interventional gastrointestinal study. The role initially involved preparing amendments, providing specialist UK advice and ensuring local regulatory guidelines were followed. Additionally I sense checked a number of documents, including the protocol, PIS/IC and advertising related documents and provided significant recommendations to help ensure smooth reviews (for 3 SA'a and one NSA. (April 22- February 23) In Sep 22, was asked to take over the CRA monitoring and oversight responsibilities for three UK sites as well as opening a fourth (SIV and set-up) for this IBS interventional study. (Sep 22-Feb 23)
Was asked to briefly return to Barts Health to manage the RECOVERY trial after the Omicron variant was detected in December 2021.
Trial manager in the Barts Health NHS Trust vaccine research centre located in the Bethnal Green Library and subsequently Mile End Hospital. Key Accomplishments: --successfully procured three new trials by preparing 'Expression of Interest' documentation and fielding sponsor queries. --set up and managed a commercial vaccine trial. (Phase II/III Study of AZD2816, for the Prevention of COVID-19 in Adults (AZD2816): clinicaltrials.gov NCT04973449 --set up and managed two individual COVID-19 medical device antigen and antibody self-test validation studies. (Panbio™ COVID-19 Antibody Self-Test Study and Panbio™ COVID-19 Antigen Self-Test Study). Both studies subsequently received their CE Mark for use by consumers directly.
• Returned to lead the RECOVERY trial in November 2020 when the pandemic's 2nd wave meant more admissions and trial participants across the Trust. • (Mar 21) 3rd highest recruiter in the country with 763 participants. • In March 2020, volunteered to assist with COVID-19 research activities for BH NHS Trust. • I was asked to lead on the RECOVERY trial (www.recoverytrial.net) as trial manager across all Barts Health sites. • Within 3 days of receiving notification, familiarised myself and then prepared a presentation to research and clinical colleagues about the trial, and proposals for how we could run this in the Trust. • Within 5 days, opened up the trial at the RLH with our first patient with the PI, lead pharmacist and doctors able and willing to recruit under very difficult circumstances. • Working with newly established COVID-19 research teams across the sites and multiple clinical teams, we enrolled 133 people across all BH sites in the first wave (from 01 April-27 June 20). In the second wave, we had a total of 763 patients (16 Apr 21) • Remit included managing 'The Nightingale' for RECOVERY, a military style hospital and was the first, in the history of the NHS, to offer clinical research alongside standard care. • The trial is looking at all hospitalised COVID-19 patients, including children, and is adaptive, with trial arms changing as more data is generated. Briefly, the trial has looked at comparing standard of care to Dexamethasone, hydroxychloroquine, Kaletra, azithromycin, colchicine, aspirin convalescent plasma, a Regeneron MAB cocktail and, for specific participants, tocilizumab. • The trial had immediate international impact, including dexamethasone becoming SOC for patients on oxygen or ventilated within one day of the results' announcement in the NHS. Tocilizumab was also effective. Additionally, it confirmed that hydroxychloroquine, Kaletra and azithromycin were indeed ineffective in this trial's cohort.
• Oversaw protocol development and trial set-up activities for a Phase IIb investigator-led trial for persons with advanced multiple sclerosis (pwAMS). (ChariotMS) This will be a national (UK), 20 centre (~200 participants), randomised, double-blind, placebo-controlled (1:1) phase IIb efficacy trial that will look to compare an IMP (cladribine) vs. placebo in preserving upper limb function. • Wrote first draft of trial protocol for submission to R&D and industry funder. This was later submitted to the HRA/MHRA and REC after revisions. • Simultaneously, assisted with developing a protocol and trial with the same participants as ChariotMS, utilising an app on a smartphone to evaluate digital biomarkers and comparing with established clinical markers. (SenseMS) This will help evaluate if pwAMS can utilise these digital tests in lieu of more traditional assessments. • Tasked with determining which data fields in SenseMS were required for industry partners to have access. This was complex as two companies were involved and both data confidentiality and intellectual property (IP) concerns needed to be addressed. • Key team member liaising with industry representatives in ChariotMS and SenseMS. • Identified central lab that will run key assays for ChariotMS. This involved deciding which tests to run centrally, cost implications and initial CDA preparation. • Reviewed EDC design with frequent suggestions for improvement • Core interviewing team member for hiring trial manager and trial monitor for ChariotMS study.
• Consulted by oncology PD-1 clinical research team regarding expertise in manufacturing and drug development timelines. Forecasted drug requirements and identified potential issues with drug availability for a new LCE PD-1 oncology protocol (now KEYTRUDA) • Learned Spectrum (CTMS), inForm (EDC) and FirstDoc (e-TMF) applications and quickly identified how to run TMF reconciliations, thus becoming very familiar with all the site level and IRB/IEC essential documents. • Trained in ICH-GCP guidelines, EU Clinical Trials and GCP Directive, SUSAR reporting, Informed Consent, drug returns and IVRS systems. • Attended eleven clinical sites with trials in oncology (PD-1), asthma, osteoporosis, C. diff infection and Alzheimer’s situated at hospital sites and SMO’s. • Increasingly ran and then led TMF reconciliation and identified inconsistencies between the clinical site and TMF. • Assisted with SDV using InForm and source patient notes at site; catalogued discrepancies and raised queries to correct them when appropriate. Collaborated with CRA's on site validation and initiation visits on PD-1 and Alzheimer’s (BACE) programs.
• Respected researcher and developer of scalable and novel synthetic chemical processes and workflows in accordance with cGMP protocol requirements; led technology transfer and demonstration of developed processes on factory scale. (45 projects in 22 years) • Collaborated across discovery chemistry, chemical engineering, and pharmaceutical formulation to research and develop synthetic chemical processes and workflows for clinical trials and safety testing. • Delivered Cozaar (Losartan) and Maxalt (Rizatriptan) to the market using in-depth understanding of pharmaceutical development, cross-functional technical reviews and regulatory requirements. • Brings sound knowledge of cGMP as applied to API development and manufacture. • Experienced with IND/NDA filing procedures and routinely updated relevant sections for e-IND, IND and CMC applications. • Managed outsourcing partners and implemented solutions ensuring results were consistent with business and project goals and budget requirements. • Received 8 milestone, achievement and team awards at MSD since 2002. These all speak to different strengths: technical prowess, team building ability and a committee membership for group morale. • Over my career, authored or co-authored 30 publications in peer-reviewed scientific journals and patents. Presented data and research at major scientific meetings in the US and Europe. • Managed and led the Devlab Focus Group (6 members) which was responsible for a yearly department meeting (of approximately 250 members), a seminar series, social events and a point of contact for employees. • Possess excellent verbal skills as demonstrated in presentations to leadership teams and senior managers to discuss progress, issues and strategies of programs. • Supervisory experience of summer students. • Selected for secondment from US to work in UK labs (Dec 1997-April 1999) Returned to UK permanently in 2001.