Helene Provstgaard

Experience

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  Barts Health NHS Trust

  Oct 2003 - Nov 2006

  Research Governance Support Officer

  Designing and maintaining the R&D database to enable accurate and timely research monitoring and reporting.Reviewing submissions for ethics and R&D approval.Provision of advice to research staff on research legislation and guidance.Review of SOPs, defining and implementing new procedures and workflows.

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  Constella Group

  Nov 2006 - Jul 2009

  Senior QA Consultant / QA Consultant

  Planning and conducting internal audits, ensuring that issues are reported, addressed and followed up.Preparation, review and update of company SOPs and Policies, ensuring that they reflect current requirements and best practice.Provision of advice to project teams on quality and compliance aspects of clinical trials.QA representative in Computer System Validation working groups to ensure compliance with 21 CFR Part 11 for internal computer systems.Preparation and delivery of internal training, such as annual GCP and legislation updates.Process improvement projects, e.g.: Internal Quality Reviews, eTMF. Show less

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  University of Oxford

  Aug 2009 - Mar 2010

  Quality Assurance Manager

  Development and implementation of a new quality management system, including development of a complete set of Standard Operating ProceduresLeading working groups on: risk assessment/management, computer system validation, data management training programmes, pharmacovigilance.Auditing to GCP and applicable legislation

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  Johnson & Johnson

  Apr 2010 - May 2012

  Specialist Global Systems QA

  Planning and conducting internal audits, including GCP/IT/PV systems, vendors and J&J operating companiesReporting observations and working with auditees to facilitate good quality CAPAsSuperuser for audit management systemProcess improvement projects, e.g.: Communication, IT & Innovation.

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  The Janssen Pharmaceutical Companies of Johnson & Johnson

  Oct 2012 - Nov 2017

  Data Quality Lead on global, cross-functional projects to develop and deliver new technologies for high quality information management and reporting (e.g. clinical trials disclosure to Health Authorities), meeting critical project timelines and GXP regulatory requirements.Lead on business analysis activities including stakeholder management, requirements gathering, business process mapping, workshops, user stories, development of new solutions, technical requirements, UAT. Agile methodology. Contributing to the creation and implementation of a new global, cross-functional information management and data governance model, including capabilities, processes, policy, and tools. E.g. lead on projects to update the data dictionary for definitions and business rules (Collibra), Master Data Management enhancements, data integration, process changes and training. Show less

  • Manager Data Quality Oversight

    Jun 2013 - Nov 2017

  • Senior Specialist Global Systems QA

    Oct 2012 - Jun 2013
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  HP Interior Design

  Nov 2018 - Mar 2023

  Business Owner - Interior Designer

  Interior design end to end services for residential clients.

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  Immunocore

  Apr 2023 - now

  Quality Systems Manager