Experience
Experience & expertise.
More than ten years in clinical trials, with a strong background in operational leadership and trial management.
UK clinical research experience
Clinical research operations
and trial management.
My experience is rooted in UK clinical research, with hands-on responsibility for study start-up and the preparation and coordination of REC, MHRA and HRA submissions. I have worked extensively with biotechnology and pharmaceutical sponsors through hosted commercial trials, alongside managing investigator-led studies within an academic sponsor organisation.
For seven years, I ran the operations of a clinical trials unit within one of Europe’s largest specialist soft-tissue sarcoma centres. This involved overseeing a portfolio of more than 50 studies, balancing study requirements with staffing, finances and recruitment, and resolving the operational issues that arose during delivery.
Trial phases & study types
Early-phase studies through
registration trials.
My hosted commercial trial experience includes Phase I, including first-in-human (FIH) studies; Phase IIa and IIb; Phase III registration trials; and combined-phase trials. At site level, I supported the delivery of registration trials and contributed study data for treatments that subsequently gained approval.
Alongside interventional trials, my experience includes observational and cohort studies, registries, biobanks and translational research protocols.
Operational expertise
- Study development and start-up: feasibility, protocol and schedule of events operational review, submission preparation and coordination, and activation.
- Budgets and funding: extensive experience with trial budgets, academic grant costings, SoECAT and the NIHR interactive Costing Tool (iCT), including previous work as a National Coordinator reviewing commercial study costings, alongside ongoing budget maintenance and financial oversight.
- Commercial site operations: recruitment and performance oversight, sponsor and vendor coordination, and management of site delivery requirements through close-out.
- Academic-sponsored trial and project management: study planning, amendments, multicentre delivery, vendor and system coordination, trial master file (TMF) maintenance and close-out.
- Research collaborations: coordination of funding requirements, material and data transfer agreements (MTAs/DTAs) and research contracts with institutional and legal teams, including collaborations with US academic laboratories. Experience also includes database transfers and transitions in study coordination.
- Operational leadership: team and portfolio management, with FDA, EMA and HTA inspection experience.
Complex operational requirements.
My early-phase oncology experience includes coordinating complex study requirements where timing, sample handling and safety reporting are critical. This has involved managing time-sensitive pharmacokinetic and pharmacodynamic (PK/PD) sampling schedules, coordinating collection and processing with clinical teams and specialist laboratories, and supporting dose-limiting toxicity (DLT) tracking and rapid safety reporting with investigators and sponsors.
For six years, I managed an international translational research programme from inception through grant delivery and expansion, connecting an academic sponsor, teams at 12 participating sites across the UK and Europe, and research laboratories. I coordinated complex sample pathways, including biopsy collection with surgical and pathology teams, alongside long-term survival follow-up using electronic patient records. My role brought these clinical, laboratory and operational activities together to support delivery across participating centres.
Research systems
Experience with clinical
research platforms.
My work has involved Medidata Rave, Veeva, OpenClinica and Epic, alongside trial-specific vendor systems. This includes working with clinical study data, essential documents and electronic patient records within established study processes.
Experience into practice
Bringing that experience
to your study.
Through Continuity, I bring this experience to academic and biotechnology teams that need additional operational expertise or capacity. I can take responsibility for a defined piece of work or provide ongoing trial management support, with a clear understanding of the study requirements and the people involved.