Experience

Advanced Clinical

• United States
• Biotechnology Research
• 700 & Above Employee

• Clinical Trial Specialist

  • Feb 2023 - Present

  Working under an FSP model for Jazz Pharmaceuticals Working under an FSP model for Jazz Pharmaceuticals



Biotherapy Services Ltd.

• United Kingdom
• Research Services
• 1 - 100 Employee

• • Nov 2021 - Jan 2023

  Working for a start-up pharmaceutical company, aiding the management of the Pharmaceutical Quality System, co-ordinating a clinical trial to GCP standards and ensuring GMP is followed whilst manufacturing biological products. - Manufacture an investigational medicinal blood product at patient bedside, working alongside NHS Healthcare Professionals to ensure it can be immediately applied after release- Assist in the set-up, organisation, and management of clinical trials, and any new trial sites- Manage the oversight of key trial vendors- Provide sponsor oversight for the set up and management of the electronic data capture system used for trials- Develop and maintain excellent working relationships with NHS staff- Review key trial documentation and assist in the preparation of Substantial Amendment Submissions- Support the research teams in ensuring the trial is managed in accordance with GCP- Manage the implementation and maintenance of a version-controlled documentation system for key trial documentation - Manage the design of patient facing materials – in accordance with ethical requirements- Manage and maintain the Sponsor Master File Show less

• • Apr 2020 - Nov 2021

  - Supported the day to day running of the BTS clinical trial, serving as a main point of contact for site research teams and key vendors. - Manufactured an investigational medicinal product at patient bedside. - Supported in deviation investigation and Corrective and Preventative Action (CAPA) implementation- Started and maintained the clinical trial risk log which allows for continued review inline with ICH Q9 on Quality Risk Management

• • Aug 2018 - Mar 2020

  - Worked as part of the manufacturing team to supply a medicinal product at patient bedside, supporting the production manager to maintain adequate starting materials, ensuring supplies were received, stored, and dispatched as per protocol. - Wrote, reviewed, and proof-read Standard Operating Procedures (SOPs), forms and policies. - Maintained a database used to manage the Pharmaceutical Quality System, ensuring SOPs, forms and policies were written, signed off, version control was kept updated and records were kept of when documentation had to be reviewed. - Wrote, proof-read, and assisted with the submission of clinical trial documentation to Ethics and the MHRA- Developed the Case Report Forms for a clinical trial, liaising with the Chief Investigator to ensure the forms would successfully capture all required data Show less



Voluntary Service Overseas

• United States
• Non-profit Organizations
• 200 - 300 Employee

• Sexual and Reproductive Health Volunteer

  • Jan 2018 - Apr 2018

  Worked and lived alongside Zambian and UK volunteers with a partner organisation - Planned Parenthood Association of Zambia (PPAZ) - designing and delivering educational sessions on sexual and reproductive health (including reproductive cancers) to school children, community members, clinic visitors and prisoners. Planned, and gained experience in the project management of Community Action Days. These were organised and fundraised for by the team to raise awareness to a wider audience of specific sexual and reproductive health issues, such as HIV and teenage pregnancy. Show less



SEK International School

• Madrid, Community of Madrid, Spain

• Laboratory Teaching Assistant (University Placement Year)

  • Aug 2015 - Jul 2016

  Planned and delivered theory-based and practical biology lessons to students ages 12-16 and helped to ensure they were ready for their exams. Planned and delivered theory-based and practical biology lessons to students ages 12-16 and helped to ensure they were ready for their exams.