Experience

Kivo

• United States
• Software Development
• 1 - 100 Employee

• Director of Clinical Services

  • Jun 2023 - Present

  Portland, Oregon, United States Support clients in implementation of eTMF/CTMS/QMS. Provision of guidance to customers in the use of Kivo clinical solutions. Support configuration, migration, integration, training and go live activities for the deployment of eTMF/CTMS/QMS. Lead and moderate communications between Sponsors and CROs during end of study transfers. Development of documentation including SOPs/work instructions, migration plans/report, TMF plans, training plans, and other documents for validated… Show more Support clients in implementation of eTMF/CTMS/QMS. Provision of guidance to customers in the use of Kivo clinical solutions. Support configuration, migration, integration, training and go live activities for the deployment of eTMF/CTMS/QMS. Lead and moderate communications between Sponsors and CROs during end of study transfers. Development of documentation including SOPs/work instructions, migration plans/report, TMF plans, training plans, and other documents for validated systems. Support the definition of trial structures, migration mapping exercises, and system adoption. Think critically about business requirements to help design a solution for customer success to promote adoption and ensure alignment of processes to system design and functionality. Consult with clients on their processes and demonstrate confidence in workflow processes in order to mentor and support clients in various functional areas to ensure their TMF success. Liaise with customers, managing communication, risks, and interactions with other vendors (CROs). Show less



IQVIA

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Associate Director, TMF Solutions

  • Nov 2021 - Jun 2023

  Washington, United States Primary client engagement position and point of contact for TMF support Building and leading new cross-functional client services Presenting at IQVIA and global TMF conferences Provision of guidance of eTMF and TMF best practices

• Customer Success Manager

  • Aug 2020 - Nov 2021

  London, England, United Kingdom Client engagement liaison for eTMF support, training, issue and query resolution Facilitation of client eTMF migrations, implementations and upgrades Performance analysis of client eTMF systems Development of the IQVIA eTMF system Client billing, PO tracking and reporting



Autolus Therapeutics

• United Kingdom
• Biotechnology
• 300 - 400 Employee

• Senior TMF Specialist

  • Jun 2018 - Jul 2020

  London, England, United Kingdom Working in Phase I/II CAR T Cell Immunotherapy trials for treatment of Cancers Management of eTMF including support, training and compliance eTMF vendor liaison Driving UAT and system validation SharePoint sites & user management Management of SOPs, policies and company training Contracts tracking and consolidation

• Clinical Trials Administrator

  • May 2016 - Jun 2018

  London, England, United Kingdom Selection, implementation, training and management of eTMF Set up and administration of Quality Management System Preparation of key site documents and Investigator Site Files Supporting the clinical team in clinical developmental activities Contracts tracking GCLP audit participation



King's College London

• United Kingdom
• Research Services

• Clinical Trials Assistant

  • May 2015 - Apr 2016

  London, England, United Kingdom • Working on a Phase II Alzheimer's Disease clinical trial • Monitoring of case report forms and source documents • Coordination of Investigational Product shipments • Coordinating collection and completion of consents • Management of Investigator Site File • Management of sub-sites • Acting pharmacy liaison • Review and development of source worksheets • Management of standard operating procedures • Ensuring GCP compliance and quality assurance • Data entry and… Show more • Working on a Phase II Alzheimer's Disease clinical trial • Monitoring of case report forms and source documents • Coordination of Investigational Product shipments • Coordinating collection and completion of consents • Management of Investigator Site File • Management of sub-sites • Acting pharmacy liaison • Review and development of source worksheets • Management of standard operating procedures • Ensuring GCP compliance and quality assurance • Data entry and data discrepancy resolution • Providing staff induction and study update training • Sponsor audit preparation Show less



Richmond Pharmacology

• United Kingdom
• Research Services
• 100 - 200 Employee

• Clinical Trials Assistant

  • Dec 2013 - May 2015

  London, England, United Kingdom • Actively working as Deputy Lab Manager, managing a small team in a lab-based environment • Working on a diverse portfolio of Phase I and II trials covering various therapeutic areas • Processing, storing and shipping human samples • Executing laboratory set up per study protocols • Performing GCP checks on case report forms • Providing study updates and query resolution to project teams, sponsors, monitors and vendors • Performing quality control checks on human samples and… Show more • Actively working as Deputy Lab Manager, managing a small team in a lab-based environment • Working on a diverse portfolio of Phase I and II trials covering various therapeutic areas • Processing, storing and shipping human samples • Executing laboratory set up per study protocols • Performing GCP checks on case report forms • Providing study updates and query resolution to project teams, sponsors, monitors and vendors • Performing quality control checks on human samples and clinical documents • Performing staff training and examinations • Creating and maintaining study-specific lab request forms and manuals • Raising shipment and supply orders • Conducting volunteer/patient screening and first pass data entry Show less



Queen Mary University of London

• United Kingdom
• Higher Education
• 700 & Above Employee

• Assistant to Academic Manager for Postgraduate Courses at WHRI

  • Aug 2012 - Nov 2013

  London, England, United Kingdom • An administrative role in the management of five postgraduate clinical programmes, collectively teaching 124 students in the academic year 2012-2013 • Ensuring student progression and coursework submission within set deadlines • Updating student records and results using an online student database system to ensure student study completion • Resolving student enquiries with regards to timetables, lectures, assignments and coursework • Assisting in student recruitment for the… Show more • An administrative role in the management of five postgraduate clinical programmes, collectively teaching 124 students in the academic year 2012-2013 • Ensuring student progression and coursework submission within set deadlines • Updating student records and results using an online student database system to ensure student study completion • Resolving student enquiries with regards to timetables, lectures, assignments and coursework • Assisting in student recruitment for the proceeding academic year • Maximising student enrolment and registration to ensure set targets are met • Arranging lecture venues and scheduling teaching staff • Arranging exam venues and associated proceedings, both on-campus and abroad • Providing feedback on student coursework • Lecturing and exam invigilating Show less