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Summary

Laura is characterized by her perseverance, she is highly motivated and eager to learn. Passionate about science, Laura decided to study Bio-science Engineering, with a specialization in Biolmolecular Engineering. The choice of a management-oriented Minor has contributed to strong communication and presentation skills and the numerous group works have made her a strong team player. Due to many tasks and projects, she is familiar with working under pressure and meeting deadlines, and working in a laboratory environment has given her sensation of GxP guidelines and proper scientific documentation techniques.

During a first professional experience, Laura gained knowledge and insight in the start-up and conduct of clinical trials, going from drafting contracts, to adjusting informed consent forms to the national template and submission to the ethics committee and regulatory authority. Hungry for new challenges, she decided to make a switch to validation, where Laura started working as a quality and compliance engineer.

Highly motivated to deliver high quality end results, Laura always makes sure that everything is handled in a proper and efficient manner.

 

 

Experiences

Current Experience

  • Quality & Compliance Engineer
    Since November 2015

    Validation of computer systems in regards to SDLC tracks.

     

    Tasks include:

    • Creation and review of SDLC documents
    • Review and initiating document approval, tracking and handling
    • Writing and follow-up of change control documents
    • Support uploading documents in HP ALM and Document Management System
    • Creation and Management Test sets in HP ALM
    • Document archiving

     

Past Experience

  • Sr ISS Coördinator
    October 2015 --- November 2015

    Clinical trial start-up is subject to very strict regulations. In order to make sure sponsors of new drugs/medical devices etc. only have to focus on product development, they are assisted by "Regulations and Start-up" in making sure the clinical trial start-up meets all national and international laws.


    Tasks included:

    - Making contact with physicians and study coordinators

    - Drafting and negotiating contracts

    - Updating and adapting Informed Consent Form to national template

    - Completing questionnaires regarding study protocols and medical substances

    - Requesting and reviewing translations of study related projects

    - Information exchange between sponsor and hospital sites

    - Submit and track records with ethics commissions and authorities

  • Summer internship
    June 2014 --- July 2014

    Summer internship "Comparative study ITS gene sequencing and MALDI-TOF MS for identification of clinical funghi". The focus of the internship was on comparison of 2 types of identification methods for clinical funghi, based on performance as wel as their costs.

Personality

Self Assessment :
Attention to detailWillingness to compromiseTrustProblem solvingInterest in knowledgeInnovative thinkingIndependenceFlexibilityCritical thinkingDependabilityCuriosityCreative thinkingCoordinationCollaborationApproachabilityAnalytical thinkingAdaptabilityStriving

Knowledge

Self Assessment :
21 CFR Part 11 Scientific writingAnalytical proceduresAseptic TechniquesAutoCADBiomedical EngineeringBusiness PlanningcGMPChange ControlChange ManagementClinical researchClinical Trial Management System (CTMS)Clinical trial managementCommunication SkillsContract negotiationCRODrug development processEngineeringFailure Mode and Effect Analysis (FMEA)GAMP5Good Clinical Practice (GCP)Good Laboratory Practice (GLP)Good Publication Practice (GPP)Good Manufacturing Practice (GMP)GXPICH guidelinesInformed Consent DocumentsInformed Consent ProcessLaboratory SkillsLaboratory TechniquesLIMSMicrosoft OfficeNew Drug Application (NDA)next generation sequencingPatient Screening and RecruitmentPharmacovigilancePresentation SkillsProcess EngineeringProject PlanningQA complianceQuality Assurance (QA)Quality Management System (QMS)Regulatory affairsRegulatory ComplianceRegulatory submissionsRisk AssessmentSequencingSQLTestingValidation
LinkedIn Assessment :
Microsoft OfficemanagementProject ManagementStrategic PlanningResearchLeadershipMicrosoft Word

Skills and Expertise

Self Assessment :
Create SOPs Develop protocols Interpret data Report data Search literature on clinical trials Technology research Write papersAnalyze dataCalculate trial timelinesCollaborate with project teamConduct university research Create study documentsData verificationData validationDesign protocolRead medical literatureReport dataReview clinical study reportsSearch literature on clinical trialsReview study protocolsStatistical analysisWrite papersWrite statistical reportsWritten presentation Use a confocal microscopyAct as the main line of communication between the sponsor and the investigatorAssess quality process issuesCommunicate with sponsorConduct literature searchesCoordinate projectsCreate SOPsDesign subject consent formEnsure good clinical practice (GCP)Ethics committee submissionsEthics committee applicationFollow-up of quality assurance activitiesInformed consent processOral presentationPlan work to meet objectives and deadlinesPrepare regulatory documentsproject managementRegulatory submissionsUse laboratory techniquesValidate dataWrite documentsWrite final reports

Education

  • Master of Bio-science engineering in Cel- en gentechnologie from KU Leuven in 2015

Training and Certification

  • Laboratory animal science certificate Certification

Languages

BrightOwl Assessment:
Self Assessment:
Dutch
Native
English
Full Proficiency
German
Full Proficiency
French
Full Proficiency
Italian
Elementary Proficiency

Work Preferences

  • Notice Period:
    5 weeks
  • Positions I am interested in:
    Clinical Research Associate (CRA) Clinical Data Reviewer Clinical Research Consultant Clinical Trial consultant Compliance Manager Field Clinical Engineer Lab Scientist Laboratory Engineer Process Engineer QA Engineer Quality Engineer R&D engineer Regulatory Affairs Consultant
  • Work From Home:
    Yes, 0 to 1 days per week
  • Work Regime:
    Permanent position :    100% FTE
  • International:
    Yes

Area / Region

Houthalen-Helchteren, België

Others

Driving License
  • Yes