Part of consultancy team advising on change management and process optimisation for eTMF
Pharmaceutical Organisation (France) Oct 2017-Oct 2018
Part of a team of consultants advising on change management and process optimisation for the implementation of an electronic Trial Master File
Pharmaceutical Organisation (Switzerland) Jan 2017-Sep 2018
Development of information governance policies
University (UK) Jan 2018-May 2018
Part of a team of consultants advising on and information governance change management for the implementation of the General Data Protection Regulations
Pharmaceutical Laboratory (UK) Jan 2018-Feb 2018
Conduct of data integrity audit for analytical sciences laboratories records
Resolution of regulatory quality management findings in relation to the conduct of clinical research activities
Chemical Research Laboratory (UK) April 2017-June 2017
Development of data preservation strategy
Pharmaceutical Distributor (UK) Jun 2013-Feb 2017
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
Development of a compliant combined records classification scheme and retention schedule based on ISO15489
Conduct of business process and gap analysis to recommend efficiency gains in operations and improved compliance in relation to record keeping for regulated activities
Project managed implementation and validation of Sage200 financial and stock control software
Revision of relevant standard operating procedures and work instructions in relation to records management
Pharmaceutical Organisation (UK) Nov 2016-Feb 2017
Advice and training on Good Laboratory Practice and Good Manufacturing Practice records management
Government Ombudsman (UK) Jun 2016-Aug 2016
Part of a team of consultants advising on records management issues for a change management project
Pharmaceutical Organisation (UK) Nov 2015-Apr 2016
Advice and training on Good Clinical Practice records management
Part of a team of consultants advising on electronic Trial Master File implementation and associated process optimisation
Pharmaceutical Organisation (Switzerland) 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 based on ISO15489
Provision of advice regarding the long-term retention and archiving of electronic records
Review of local and international legal and regulatory record keeping requirements
Pharmaceutical Organisation (Switzerland) 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 EU record classification schemes
District Council (UK) Jan 2015-Feb 2015
Development of user requirements specifications for- and evaluation of- document management solutions
Borough Council (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
Pharmaceutical Organisation (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 (UK) Sep 2011-Apr 2013
Conduct of gap analysis to provide an 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 (UK) Nov 2012-Apr 2013
Provision of advice 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.
Worked with senior managers and key stakeholders in Clinical Commissioning Groups to develop 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.
Executive Non-Departmental Public Body (UK) Apr 2012-Aug 2012
Compilation of a global information asset register and provision of a strategic report recommending approaches to: mitigate physical & 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.
Pharmaceutical Organisation (UK) Jun 2011-Dec 2011
Developed records classification scheme & retention schedule based upon business processes in preparation for introduction of a new document management system, including review of associated policies & procedures.
Developed a business continuity plan and drafted supporting processes & procedures.
Pharmaceutical Distributor (UK) Aug 2011-Dec 2011
Provided advice on records collection, classification, retention & scanning solutions in relation to pharmaceutical manufacturing and supply records.
Provided advice on validation requirements for new document management system used for the management of pharmaceutical manufacturing and supply records.
Pharmaceutical Organisation (Germany) Oct 2011-Nov 2011
Mapped multifarious clinical trial master file plans to a new centralised file plan.
Pharmaceutical Organisation (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.
