Experience

Phlexglobal, A PharmaLex Company

• United Kingdom
• Pharmaceutical Manufacturing
• 200 - 300 Employee

• TMF Study Owner for Chiesi at Phlexglobal

  • Dec 2022 - Present

• TMF Study Owner for Pfizer at Phlexglobal

  • Jul 2021 - Dec 2022

  • Monitor completeness and quality of TMF content for all assigned clinical trials until close out• Support Study Team to ensure document quality requirements are agreed to and met, according to Completeness, Timeliness and Quality metrics• Serve as point of contact for internal and external audits of a study TMF related queries.

• Document Quality Specialist

  • Dec 2013 - Aug 2021

• Quality Co-ordinator

  • Oct 2013 - Nov 2013

• Study Support Specialist

  • Jul 2013 - Sep 2013

• Clinical Trial Administrator

  • Nov 2011 - Jun 2013

  • Pre Audit / Inspection / QC review of documentation in accordance with Phlexglobal Ltd or the client company SOPs• Set up of TMF and Investigator Sit Files on behalf of the client company, in accordance with client company SOPs or Phlexglobal Ltd SOPs and ICH GCP• Devising new filing structures as well as basic filling maintenance • Set up and maintenance of electronic filling templates• Preparation of documentation for Archive, in accordance with Phlexglobal Ltd SOPs and industry standards• Other appropriate CTA duties as and when required Show less



Convatec

• United Kingdom
• Medical Equipment Manufacturing
• 700 & Above Employee

• CTA (secondment )

  • Feb 2013 - May 2013

  • Overall trial support including preparation and shipping of documents and supplies. • Creation and updating screening and recruitment spreadsheets. • Organising courier collections and deliveries of documents and unused supplies after site closure/study end. • Receiving, storage and disposing of unused returned supplies. • Tracking all supply movement on forms and spreadsheets. Creating, filing and archiving trial files. • Overall trial support including preparation and shipping of documents and supplies. • Creation and updating screening and recruitment spreadsheets. • Organising courier collections and deliveries of documents and unused supplies after site closure/study end. • Receiving, storage and disposing of unused returned supplies. • Tracking all supply movement on forms and spreadsheets. Creating, filing and archiving trial files.



Convatec

• United Kingdom
• Medical Equipment Manufacturing
• 700 & Above Employee

• CTA ( secondment )

  • Nov 2011 - Jul 2012

  • Overall trial support including preparation and shipping of documents and supplies. • Creation and updating screening and recruitment spreadsheets. • Organising courier collections and deliveries of documents and unused supplies after site closure/study end. • Receiving, storage and disposing of unused returned supplies. • Tracking all supply movement on forms and spreadsheets. Creating, filing and archiving trial files. • Overall trial support including preparation and shipping of documents and supplies. • Creation and updating screening and recruitment spreadsheets. • Organising courier collections and deliveries of documents and unused supplies after site closure/study end. • Receiving, storage and disposing of unused returned supplies. • Tracking all supply movement on forms and spreadsheets. Creating, filing and archiving trial files.