Experience

TOMBERRIES NURSERY LIMITED

• United Kingdom
• Education Administration Programs
• 1 - 100 Employee

• Director

  • Aug 2018 - Present



PRA Health Sciences

• United States
• Research Services
• 700 & Above Employee

• Clinical Study Manager

  • Jan 2017 - Aug 2018

  Clinical Study Manager in early clinical development. PRA parnership colleague supporting Takeda.

• Senior Study Support Associate

  • Oct 2016 - Dec 2016

  PRA partnership colleague supporting Takeda trials in the same capacity as before.



Takeda Pharmaceuticals Europe Ltd

• Senior Study Support Associate

  • Feb 2014 - Oct 2016



Covance

• Clinical Research Administrator & Global Clinical Trial Start-up Administrator

  • May 2012 - Jan 2014

  • Co-ordinate the project team concerning all administrative clinical trial matters.• Provide clerical support for clinical projects; project directors, clinical & start-up project managers, clinical research associates and other team members in accordance with project specific and Covance standard operating procedures.• Set up and maintain the central project files (TMF), investigator files (IF) and other project related administrative activities on a global scale.• Create and/or maintain administrative systems validity and integrity (eTMF, CTMS, EDC, RAVE, Lotus notes Trial Tracker and Excel based systems) for clinical projects in accordance with project specific and Covance standard operating procedures.• File reviews and quality control checks of study/site files, investigator files (IF) & central project files (TMF) to ensure and maintain MHRA, client & internal audit readiness.• Create, validate and manage global investigator payments over the trial period including consolidating and reconciling outstanding payments in accordance with agreed budgets.• Mentored, produced training materials and also trained and supported new employees on Covance procedures, study tasks and general competencies.• Prepare Monitoring visit documentation and co-monitored with Clinical Research Associate on feasibility assessments, site initiation visits, routine monitoring visits, close out visits.• Direct interaction with sites and sponsors resolving queries, managing expectations and reporting project statuses.• ICH-GCP training and understanding.• Trained on Conducting Feasibility on sites for clinical trial participation/suitability.• Trained on Regulatory/Ethics requirements, submissions & approvals process.• Trained on Informed consent development, procedures and importance.



ICTS Europe

• France
• Security and Investigations
• 700 & Above Employee

• Security Agent; Profiler

  • Mar 2012 - May 2012