Laszlo Mindak

Experience

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  AstraZeneca

  May 2007 - Oct 2011

  Clinical Research Associate

  Initiating Phase II-IV. studies, monitoring, performing feasibilities, RA/EC submission, budget planning and review, coordinating the work of sites/monitors/study assistants from the very beginning via initiation to centre closure. On the job training for new CRAs.

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  ICON plc

  Nov 2011 - Aug 2018

  Responsibilities include (in addition to those which are noted under QCA) :Leading an enhanced Quality Compliance initiative globally for studies determined to fall under high risk based on pre-defined indicators.Performing Site Assessment Visits for new studies transitioning to ICON from Pfizer/GSK.Working on Six Sigma and other projects on enterprise level (eg Inspection Readiness, Time Management, Project Issues).More than 100 Quality Events – from site to enterprise, from country to global level - have been led internally, involving several Functional Lines (eg ClinOps, DM, SSU, Legal, Regulatory, Medical Writing, QA) to remediate issues appropriately. Show less Responsibilities include:Act as an expert advisor on ICH GCP, ICON SOPs/WPs and all stages of study set-up, monitoring and study close-out for assessment of quality compliance processes for monitoring activities within Pfizer Strategic Business Unit.Leading and facilitating cross-functional (among departments and Sponsor/CRO) Root Cause Analysis and CAPA implementation for Quality Issues, tracking in QMS until completion.Become involved, when required, in other areas of services and staff training and contribute to the review of ICON systems and quality procedures as appropriate (global TMF process improvement, CRA oversight).Assist in tracking departmental quality compliance in processes and departmental metrics. Contributing in preparation of PSBU Quality Forums and Portfolio Reviews, analyzing Qualifying Quality Issues data.Assisting Clinical Trial Process Quality Standards of Pfizer on enterprise level: Informed Consent Document, Registry Data, Qualifying Quality Issues, Vendor Oversight, Investigational Product Management). Show less Responsibilities include:Acting as liaison between the Project Manager/CTM and a group of Clinical Research Associates. Primary point of contact for assigned CRAs to ensure the delivery of site management activities from site selection to the close out visit, in adherence with ICH/GCP, SOPs, applicable regulations, Monitoring Plan and study contract/budget. In addition, assisting the CTM in the development of study specific documents, providing training/mentoring to CRAs and ensuring a timely dissemination of information on study progress, issues, and/or processes to all team members related to the clinical deliverables. Ensure accurate tracking of any relevant study information and assist the PM/CTM in implementing quality standards and ensuring compliance with study metrics requirement as set by the contract and the PM/CTM. Show less Responsibilities include:Studies are carried out according to the study protocol, ICON SOPs/WPs, applicable regulations and the principles of ICH-GCP in EU countries.Involvement of study management and staff training on a daily basis. Contribute to the review of ICON systems and procedures, as appropriate.Coaching and mentoring of monitoring competence to inexperienced/less experienced colleagues.Reviewing and approving of the monitoring visit reports of the CRAs.Contribute to the culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs. Recognize, exemplify and adhere to ICON’s values which centre around a commitment to People, Clients and Performance.Independently and proactively coordinate the necessary activities required for a study. Show less

  • Quality Compliance Lead

    Oct 2017 - Aug 2018

  • Sr Quality Compliance Associate

    Apr 2016 - Sept 2017

  • Quality Compliance Associate

    Jan 2014 - Mar 2016

  • Associate Clinical Trial Manager

    Oct 2013 - Jan 2014

  • Lead CRA

    Jan 2013 - Sept 2013

  • Sr CRA QC

    Nov 2011 - Dec 2012
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  Accelsiors CRO

  Aug 2018 - Jun 2021

  Having a key role to strategically support the company for exploring and identifying significant process development needs, as well as implementing them based on business requirements. Leading internal and external projects to achieve targets and strategic objectives. This role also involves active participation with Sponsor communication and development of business solutions across the company. Acting as Head of QA. Responsible for oversight of global QA tasks, including audit plan, Vendors, Client audits and Regulatory inspections, QMS, CAPA management, internal quality investigations, process improvement initiatives, risk management. Training, mentoring and line management of QA members. Performing Vendor qualification and Site audits.

  • Exec. Dir. Process Development & Integration

    Sept 2020 - Jun 2021

  • Associate Director Quality Assurance

    Aug 2018 - Aug 2020
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  EastHORN Clinical Services

  Jul 2021 - Dec 2022

  Director Of Quality Assurance
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  Novotech

  Jan 2023 - Dec 2024

  Director of Quality Assurance
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  Simploud

  Jan 2025 - now

  Solutions Architect