Projects

Global Pharmaceutical Distributor, Kent, UK (Jun 2013 – Dec 2016)

  • Lead respondent in client audit in relation to governance issues related to supply of compassionate use medicines
  • Provision of advice and assistance with eTMF and EDC solutions user requirements and functional specifications
  • Project Manager for implementation of fully validated electronic document and quality management system
  • Analysis of the business’ functions, activities and records collections to facilitate the development of a compliant combined records classification scheme and retention schedule based on ISO15489
  • Business process and gap analysis to recommend efficiency gains in operations and improved compliance in relation to record keeping for regulated activities
    Project management of validation and implementation of Sage200 financial and stock control software
  • Revision of relevant standard operating procedures and work instructions in relation to records management

Pharmaceutical Organisation, Yorkshire, UK (Nov 2016)

  • Provision of advice and training on records management and information governance in relation to Good Laboratory Practice and Good Manufacturing Practice

Global Pharmaceutical Organisation, Surrey, UK (Nov 2015)

  • Provision of advice and training on records management and information governance in relation to Good Clinical Practice and Trial Master File management

Global Pharmaceutical Organisation, Copenhagen, DK (Sep 2015 – Dec 2015)

  • Part of a team of consultants advising on change management and associated process optimisation for electronic Trial Master File implementation

Global Pharmaceutical Organisation, Paris, FR (Apr 2015 – Oct 2015)

  • Part of a team of consultants advising on change management and associated process optimisation for electronic Trial Master File implementation

Global Pharmaceutical Organisation, Arlesheim, CH (Mar 2014 – Sep 2015)

  • Analysis of the business’ functions, activities and records collections to facilitate the development of a compliant combined records classification scheme and retention schedule
  • Provision of advice regarding the long-term retention and archiving of electronic records
  • Review of local and international legal and regulatory record keeping requirements

Global Pharmaceutical Organisation, Basel, CH (Feb 2014 – Apr 2015)

  • Creation of ISO 27001 compliant information security classification policies and procedures
  • Development of criteria for the evaluation of existing and new electronic records management systems
  • Mapping of US and European records classification schemes

District Council, Home Counties, UK (Jan 2015 – Feb 2015)

  • Development of user requirements specifications for- and evaluation of- document management solutions

Borough Council, South Coast, UK (Jan 2014 – Nov 2014)

  • Analysis of the business functions, activities and records collections to facilitate the development of a compliant combined records classification scheme and retention schedule based on ISO15489

Global Pharmaceutical Organisation, Edinburgh, UK (Dec 2012 – Dec 2014)

  • Provision of records management services including RM training and advice, review of applicable standard operating procedures and assessment of requirements for the introduction of an electronic trial master file

District Council, Home Counties, UK (Sep 2011 – Apr 2013)

  • Gap analysis to provide independent assessment of the current state of records management within the authority (including a proposed transition to commercial records storage arrangements) to recommend strategies required to ensure “fitness for purpose”

NHS Primary Care Trust, Home Counties, UK (Nov 2012 – Apr 2013)

  • Provision of advice to the Primary Care Trust in the management of paper and digital records during transition and closure, ensuring that records passed to Clinical Commissioning Groups were transferred, archived or destroyed in compliance with the NHS Code of Practice on Records Management and Information Governance Principles
  • Working with senior managers and key stakeholders in Clinical Commissioning Groups developed functional file plans and associated guidance to provide staff with the tools and knowledge to manage records effectively and encourage the adoption of compliant records management practices for the future

UK Government Global Cultural Organisation, London, UK (Apr 2012 – Aug 2012)

  • Compilation of a global information asset register for the organisation and provision of a strategic report recommending approaches to: mitigate physical and security risks; improve information governance through the adoption of records management policies and procedures; support the leveraging of information assets for business use and commercial advantage; and ensure effective planning for the introduction of new IT systems and the migration of content into them

Bio-Technology Organisation, Oxfordshire, UK (Jun 2011 – Dec 2011)

  • Developed records classification scheme and retention schedule based upon business processes in preparation for introduction of a new document management system, including review of associated policies and procedures
  • Development of business continuity plans and supporting processes and procedures

Global Pharmaceutical Distributor, Hertfordshire, UK (Aug 2011 – Dec 2011)

  • Provision of advice on records collection, classification, retention and scanning solutions in relation to pharmaceutical manufacturing and supply records
  • Provision of advice on validation requirements for new document management system used for the management of pharmaceutical manufacturing and supply records

Global Pharmaceutical Organisation, North Rhine-Westphalia, DE (Oct 2011 – Nov 2011)

  • Mapped multifarious clinical trial master file plans to a new centralised file plan

Global Pharmaceutical Organisation, Buckinghamshire, UK (Aug 2011 – Nov 2011)

  • As part of a consultancy team, provided support in preparation for development and implementation of an electronic document management system and supporting processes based upon insight into and experience of industry trends, applicable regulatory and legal requirements, and best practice for records management