Experience

Sanofi Netherlands

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Business Analyst

  • Dec 2021 - Present



Kiadis Pharma

• Netherlands
• Biotechnology
• 1 - 100 Employee

• Sr. Clinical Systems Lead

  • Mar 2021 - Present

  Clinical Operations administrative support for phase I-III global cell therapy based hematology- oncology studies. Managed day to day implementation of eTMF (Veeva Vault) working with internal and external CRO staff. Developed eTMF training program, and trained internal and CRO based staff on eTMF processes. Review of completeness and inspection readiness of paper and electronic TMF. Preparing paper TMF for transition to eTMF. SME for audit of CRO eTMF. Participated in configuration and implementation team for Kiadis Veeva eTMF (super user). Project lead for selecting vendor to migrate paper TMF into Veeva eTMF. Developed Vault TMF tracking tools and dashboards to monitor eTMF completeness and status checks.Supported study teams in review and completeness checks of site regulatory documents. Prepared study files for internal QA audits. Participated as member of regulatory inspection team. Tracked and reported Inspector questions and answers provided, tracked documents provided to inspectors. Performed TMF completeness checks and readied paper and electronic trial files for site and study close-out, and prepared files for archiving per company procedures. Performed backup CTA duties covering general administrative tasks.

• Sr. Clinical Trial Assistant

  • Oct 2018 - Mar 2021



DOCS

• Clinical Research Associate

  • Mar 2017 - May 2018



GSK (outsourced by DOCS)

• Zeist

• Clinical Research Associate

  • Mar 2017 - Jan 2018

  Intensive CRA training program for both GSK and DOCS. Preparing, collecting and quality check of site- and study-specific documents (for site activation, close out and ongoing documents during study). Training during Investigator meeting and on site. Performing on-site and remote monitoring visits according to monitoring plan. Source document review and source data verification. Write visit reports and follow up on action items. Discuss recruitment and planning with site staff. Site feasibility and site selection (together with project manager). Site initiation and close out visits (co-visits). Monitoring of study milestones. Care for continuous ICH-GCP and SOP compliance. Follow-up on deviations. QC of documents filed in ISF and eTMF.



Johnson & Johnson (outsourced by DOCS)

• Leiden

• Clinical Trial Assistant

  • Oct 2016 - Jan 2017

  Administrative support for a global phase III study. Arrange GCP and IST training for (new) investigators. Compiling reports from IVRS and CTMS. Maintain minutes. Filing of study documents on SharePoint and in vTMF. Tracking of study budgets and invoices. Handle correspondence. Site selection for review of monitoring visit reports. Quality review of trial documents. Administrative support for a global phase III study. Arrange GCP and IST training for (new) investigators. Compiling reports from IVRS and CTMS. Maintain minutes. Filing of study documents on SharePoint and in vTMF. Tracking of study budgets and invoices. Handle correspondence. Site selection for review of monitoring visit reports. Quality review of trial documents.



Portola Pharmaceuticals (outsourced by DOCS)

• Home-based

• Clinical Trial Assistant

  • Aug 2013 - Jul 2016

  Administrative support for a global phase III study. Creating and maintaining tracking tools and study status reports in accordance with study requirements. Quality review and updating of CTMS. Coordination and quality check of translations of submission documents and approvals. Review of country-specific ICFs. Preparation of EU Clinical Trial Application Forms. Preparation and review of country-specific submission packages to IRB/IEC. Document collection for submission to the FDA. Study Start up activities (site selection and feasibility). Creating Study Site Files. Collecting and filing of study documents in the eTMF. Quality review of essential documents. eTMF review on completeness and follow up on action items. Organizing and attend study team trainings at locations in Europe and by WebEx. Organizing and attend Investigator Meetings. Assembling and distribution of study materials to team members and study sites. Training and support of new study team members to various study systems (administrator role).



Julius Clinical

• Netherlands
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Clinical Trial Assistant

  • Jul 2011 - Jul 2013

  Administrative support to national and global clinical trials and investigator initiated studies. Involved in recruitment of general practitioners and responsible for contracts and payments. Follow-up of participants. Set up and management of Trial Master File and Project Master File. Creation and management of study documents, tools and templates, newsletters and tracking tools. Collecting data from internal and external sources in order to create study status reports. Prepare monitoring visits. Co-monitoring. Solving findings compliance check.



UMCN

• Hospitals and Health Care
• 1 - 100 Employee

• Postdoc at the Orthopaedisch Research Laboratory

  • Sep 2006 - Sep 2008

  Research on the use of natural collagen scaffolds for the repair of cartilage defects. I supervised several students with their internships, gave practical teaching to small groups of students and directed two lab analysts in their daily work. Dutch: Onderzoek naar de mogelijkheden om met behulp van collagene dragers (scaffolds) kraakbeen te maken. Daarnaast begeleidde ik diverse studenten bij hun stages, gaf ik praktijkgericht onderwijs aan kleine groepen studenten en stuurde ik 2 analisten aan in het dagelijks werk. Belangrijkste werkzaamheden: * Opzetten en valideren nieuwe labtechnieken (celkweek, elisa’s, RNA en DNA werk, qPCR) * Opzetten van kweeksysteem en assays voor humane stamcellen en chondrocyten * Isoleren van cellen uit kraakbeen en deze in kweek brengen * Testen van weefselingroei in scaffolds van verschillende samenstelling/materialen in proefdieren