An experienced data-driven clinical research professional, I've worked in clinical trials since obtaining my PhD from the University of London. My thesis explored the genetic basis of small vessel disease, a subtype of lacunar stroke. Since then, I've worked in clinical research as a project manager at a Phase I CRO, a trial manager within a UKCRC accredited Clinical Trials Unit, managed individual investigator-initiated clinical trials nationally and internationally, monitored academic trials as a Clinical Research Associate and most recently have been a Medical Writer at CROs and within the charity sector.
My experiences have shaped the individual I am today — a conscientious professional who prides herself on authoring clinical documentation to the highest standards, compliant with relevant guidelines, templates and style guides, within timelines and to budget. The main attributes I can offer are:

• Comprehensive Sector Experience: Extensive expertise across academia, industry, and the charity sector, providing a well-rounded perspective in medical writing
• Guideline and Template Expertise: In-depth knowledge of key guidelines and templates, including ICH E3/E6/E9, CORE Reference and TransCelerate templates, ensuring high-quality, compliant documentation
• Trial Design Knowledge: Solid understanding of clinical trial design, including innovative methodologies such as umbrella trials
• Data Management Skills: Proficiency in handling and manipulating large datasets in Microsoft Excel accurately and efficiently
• Document Management Software: Proficiency with Veeva, PleaseReview, Citrix based systems and Sharepoint
• Collaborative Teamwork: Experience in working as part of cross-functional teams, facilitating collaboration across departments
• Regulatory Knowledge: Familiarity with the requirements of global regulatory agencies, including FDA, EMA, TGA and PMDA. Experience acting as the main contact with the MHRA for an advanced therapy trial sponsored by a leading academic teaching hospital
• Specialised Regulatory Submissions Expertise: Experience in the submission of Clinical Trial Applications (CTAs), including an understanding of trials requiring ARSAC approval, and those involving children or incapacitated adults
• Extensive GxP Knowledge: Strong understanding of Good Clinical Practice, Good Manufacturing Practice and Good Distribution Practice as they pertain to cell and gene therapy trials, as well as Good Pharmacovigilance Practices, ensuring compliance with regulatory standards across all trial phases