Fiona Denat
London
Summary
- Clinical Study Leader
- Oncology (NSCLC, GBM, MM)
- PhD
Overview
17
17
years of professional experience
Work History
Study Management Associate III
AbbVie Ltd.
Maidenhead, Berkshire
12.2013 - Current
- Solid Tumour Therapeutic Area (Clinical Development) Rotation
- 20% time allocation to gaining experience of the TA Scientific Director (TA SD) job role in solid tumours (NSCLC) including: Weekly 1:1 with TA SD mentors, ad hoc introductory 1:1 with other functional areas, Personal research into treatment and competitive landscapes, Protocol writing, comparison of protocols in the program for consistency, SSL review, Attendance to TA specific meetings.
- Working within the global Clinical Study Leadership team to coordinate design/start up of a phase I/II study in multiple myeloma, enterprise critical. Extensive role in protocol amendment content - collaboration with TA MD and scientific director, Consent form language creation, Set up of study vendors, particularly central lab vendor, CSL Lead for EDC development: Significant input to CRF design and EDC Specs as well as IRT.
- Working within the global Clinical Study Leadership team on a fast recruiting phase I study in multiple myeloma, enterprise critical. Main responsibility was oversight of central lab vendor, and equipment provisioning vendor, Extensive role in protocol amendment content.
- Working within the global Clinical Study Leadership team to coordinate design/start up of a phase I/II study in NSCLC. Extensive role in study design and protocol review, responsible for consent form language creation. Exploring operational considerations for platform study design.
- Following another year’s maternity leave, working within the global Clinical Study Leadership team to coordinate study management of a phase 1b study in multiple myeloma, enterprise critical study. Main responsibility to create CRA and Site training slide deck. This involved extensive protocol review and involvement in set up of vendors and study operations such as cohort management plan, Held IRT training for CRAs, Responsible for study team meeting minutes and allocation of tasks, and ensuring all start up activities completed per AbbVie processes, and oversight of production of study tools/documents.
- Following a year’s maternity leave, working within the global Clinical Study Leadership study team to coordinate study management of phase II study in myelofibrosis, enterprise critical study. Responsibility for oversight of start up of 5 countries including weekly stand up calls with monitors, Collaborative working with team of 5 other SMAs to facilitate design/execution of study during recruitment and maintenance phases, Responsibilities have included oversight of patient recruitment website and other patient recruitment strategies e.g patient and physician outreach, TMF review/oversight, Study execution plan updates, design/oversight of additional study tools for priority study, holding Study coordinator and Investigator calls, chairing team calls on rotation.
Senior Clinical Research Associate
PAREXEL International
Maidenhead, Berkshire
08.2013 - 11.2013
- Duties as for CRA II, but including Training/Mentoring new/junior CRAs, UK/Ireland Study Lead responsibilities of a recruiting phase IIIb trial in ulcerative colitis, Leading a team of 4 other CRAs and 1 admin assistant/junior CRA. 12 sites and ¼ global patients recruited – globally the highest recruiting affiliate.
- Responsible for Ethics and R&D submissions, “Country concierge” role coordinating fast UK set up of a critical CRO-run phase II oncology (CLL) study. 11 sites identified. Assist with: Contract/budget negotiation, New site identification, Liaising with local networks to prioritise set up locally, Coordinating Ethics Committee response inc PIS rewrite, Working with the CRO and with study team and affiliate to identify areas for speeding up set up of study, in attempt to meet challenging timeline targets.
Clinical Research Associate II
PAREXEL International
Maidenhead, Berkshire
12.2012 - 08.2013
- Conduct the clinical monitoring aspect of a recruiting phase IIIb trial in ulcerative colitis, Perform on-site monitoring activities (drive patient recruitment, source data verification, drug accountability, data collection), Coordinate set up activities (contract/budget negotiation, essential doc collection, IP release), Collect regulatory documentation, Site visits: pre-study, SIV, re-training and routine monitoring.
Clinical Research Associate
PDR Partners
Welwyn Garden City, Hertfordshire
11.2011 - 11.2012
- Conduct the clinical monitoring aspect of phase Ib (oncology) and phase IV (renal anaemia) trials, Perform on-site monitoring activities (source data verification, drug accountability, data collection), Perform remote monitoring activities (eCRF compliance checks, drug management, site query resolution), Collect regulatory documentation.
Clinical Trial Coordinator
CR-UK & UCL Cancer Trials Centre
London
04.2010 - 11.2011
- Coordinate set up and management of new and on-going academic glioblastoma clinical trials (phase “O” and II), Obtain ethics and regulatory approvals for new studies and amendments, Design of protocols, trial documents for TMF and site files, study management SOPs, paper CRFs, databases, IWRS system, blinding procedures, Perform on-site monitoring activities (initiation, source data verification, drug accountability, data collection), Coordinate investigator and trial management group meetings, Coordinate contracts between Sponsor and investigational sites, and industry collaborators.
Study Coordinator
Cancer Prevention Trials Unit, Queen Mary University
London
07.2009 - 03.2010
- Coordinate set up and management of new academic clinical studies (non-IMP – breast cancer screening and early detection assays), Obtain ethics and regulatory approvals for new studies and amendments, Design of protocols, trial documents for TMF and site files, study management SOPs, eCRFs, Perform central monitoring of sample and data collection, on-site initiation/training visits.
Clinical Trial Administrator
Kings Musculoskeletal Trials Unit, Kings College London
London
03.2009 - 07.2009
- Check paper-based CRFs, raise discrepancies with site staff, data entry
- Maintain centrally-held Trial Master Files
- Coordinating retrieval of data including CRFs and patient x-rays from sites
- Trained to carry out on-site SDV and site file checks.
Education
PhD - Biochemistry
University of Sussex
Falmer, Brighton01-2009
BSc (Hons) - Zoology
University of Bristol
Bristol01-2004
Skills
- Protocol design
- Global delivery
- Cross-functional leadership
- Operational efficiency
- Vendor management
Publications
- Multi-Center Randomized Phase II Study Comparing Cediranib plus Gefitinib with Cediranib plus Placebo in Subjects with Recurrent/Progressive Glioblastoma., Brown et al, PLoS One, 2016-05-27, 11, 5, e0156369, https://www.ncbi.nlm.nih.gov/pubmed/27232884
- A randomised trial of weekend and evening breast screening appointments., Offman et al, British Journal of Cancer, 2013-01-01, 109, 597–602
- Mammographic surveillance in women younger than 50 years who have a family history of breast cancer: tumour characteristics and projected effect on mortality in the prospective, single-arm, FH01 study., Duffy et al, Lancet Oncol, 2010-12-01, 11, 12, 1127-34
- Enhanced radiosensitisation of human glioma cells by combining inhibition of PARP with inhibition of Hsp90., Dungey, F.A, Chalmers, A.J., Molecular Cancer Therapeutics, 2009-08-01, 8, 8, 2243-54
- Replication-dependent radiosensitisation of human glioma cells by inhibition of poly(ADP-ribose) polymerase: mechanisms and therapeutic potential., Dungey, FA; Loeser, DA; Chalmers, AJ;, Int J Radiat Oncol Biol Phys, 2008-11-15, 72, 4, 1188-97
- Anti-Trypanosomal activities of DNA Topoisomerase Inhibitors., Deterding, A; Dungey, FA; Thompson, KA; Steverding, D;, Acta Tropica, 2005-03-01, 93, 3, 311-6
Personal Information
Maiden Name: Dungey
CV Date
21 Feb 2026
Timeline
Study Management Associate III
AbbVie Ltd.
12.2013 - Current
Senior Clinical Research Associate
PAREXEL International
08.2013 - 11.2013
Clinical Research Associate II
PAREXEL International
12.2012 - 08.2013
Clinical Research Associate
PDR Partners
11.2011 - 11.2012
Clinical Trial Coordinator
CR-UK & UCL Cancer Trials Centre
04.2010 - 11.2011
Study Coordinator
Cancer Prevention Trials Unit, Queen Mary University
07.2009 - 03.2010
Clinical Trial Administrator
Kings Musculoskeletal Trials Unit, Kings College London
03.2009 - 07.2009
PhD - Biochemistry
University of Sussex
BSc (Hons) - Zoology
University of Bristol