Clinical Project Manager

Clinical Development Manager with a proven track record in managing global MedTech and SaMD trials, ensuring compliance with FDA and EU MDR regulations, and leading cross-functional teams to success.

Expert in clinical trial management, regulatory submissions, and budget oversight, with a focus on AI-based diagnostics and Class III medical devices, delivering high-quality outcomes across multiple geographies.

Skilled in developing and executing clinical protocols, managing vendor relationships, and ensuring audit readiness, with extensive experience in NHS, academic, and digital health collaborations.

Adept at authoring regulatory documents, conducting systematic literature reviews, and maintaining PMS/PMCF strategies to ensure ongoing device safety and performance tracking.

Led international clinical research programmes, including FDA and EU MDR studies, covering pivotal, precision, and post-market trials across multiple geographies

Oversaw study operations from feasibility through to closeout, including regulatory submissions, country/site selection, and IRB/ethics approval processes

Managed vendor relationships, study budgets, timelines, and contract deliverables to ensure consistent, high-quality outcomes

Directed cross-functional teams including data management, medical writing, QA, and regulatory affairs to deliver compliant and audit-ready trial documentation

Conducted systematic literature reviews to support Clinical Evaluation Reports (CERs) and Post-Market Clinical Follow-up (PMCF) activities

Developed and maintained PMS/PMCF strategies to ensure ongoing device safety and performance tracking

Authored and revised Standard Operating Procedures (SOPs), supporting continuous process improvement and inspection readiness

Managed multiple global clinical studies for AI-based medical devices, leading cross-functional teams across clinical operations, regulatory, and data science

Conducted feasibility assessments, site selection, and site start-up for international trials aligned with FDA and UKCA requirements

Oversaw regulatory submissions, study budgets, CRO/vendor deliverables, and performance metrics to ensure study timelines and quality objectives were met

Authored key regulatory documents, including Investigator Brochures and protocols, in compliance with GCP and FDA expectations

Developed SOPs, CRFs, and QA procedures to standardise trial execution and maintain data integrity

Provided mentorship to junior CPMs and led collaborative efforts with regulatory teams to prepare Clinical Evaluation Reports (CERs) and submission packages

Headed the Trial Management Unit (TMU), providing oversight and strategic leadership for a team managing multi-specialty clinical trials

Delivered end-to-end trial management including REC, HRA, and MHRA submissions for CTIMPs and device trials, ensuring compliance with ICH-GCP

Led budgeting, investigator negotiations, site initiation, monitoring, and stakeholder communications across industry and academic trials

Designed essential study materials (protocols, CRFs, databases) and mentored junior researchers in trial execution and regulatory documentation

Collaborated with NHS clinicians, universities, and commercial partners to implement high-impact research in cardiology, dermatology, oncology, and infectious disease