Enthusiastic GPhC registered Pharmacist and CPhOGH Fellow currently working as a Regulatory Advisor/Project manager for phase I to IV global clinical trials of medicinal products and medical devices. Extensive experience within all therapeutic areas. Accountable for oversight and management of clinical trial life cycle from grant applications for funding and contract negotiations with vendors. Preparation and submission of CTAs for submission to MHRA. Preparation of protocol and essential documents to ethics. Maintenance and oversight of TMF/eTMF CTMS and other databases. Preparation of documentation for CE marking to notifiable bodies. Trained monitor. Responsible for IMPD and IB collation. Extensive scientific and medical knowledge including ICH GCP, ISO 13485 and EU Directives including the MDR. Experience in running research overseas and involved with multiple research projects and manuscript publications.