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Experiences

Current Experience

  • sr CRA

    NLD, BEL
    Since November 2013

    ● site management of studies Phase III ● feasibility management and contracts ● develop study budget, Planning of resource, Training ● managing Clinical sites, ensuring and reporting overall timelines ● cross development functionality ● monitoring and review ● investigators and monitors meetings ● kol management and initiating and Planning/reviewing Investigator driven studies ● ensure safety, quality and success of project in Compliance with corporate strategies, SOP’s and ich/gcp ● inspection/audit Training and readiness, capa handling ● Clinical document and qc management

    ● site management of studies phase III ● Feasibility management and contracts ● Develop study budget, planning of resource, training ● Managing clinical sites, ensuring and reporting overall timelines ● cross development functionality ● Monitoring and review ● Investigators and Monitors Meetings ● KOL management and initiating and planning/reviewing Investigator driven studies ● Ensure safety, quality and success of project in compliance with Corporate Strategies, SOP’s and ICH/GCP ● Inspection/audit training and readiness, CAPA handling ● Clinical Document and QC Management

Past Experience

  • Clinical pharmacology study manager NLD

    February 2009 --- November 2011

    ● international projectmanagement of Clinical studies Phase I ● development and writing of protocols and study designs ● full study/project budget ● managing CRO, ensuring and reporting overall timelines ● monitoring review ● Leadership of study/project­teams, Member of Expert development teams ● cross functional cmc, cdm, plm, qa, labs ● site/Investigator selection (feasibility management) ● overall responsibility for CRO and other vendors, timelines and recruitment, pk/pd, study drug management, tmf, Data Management including topline reporting ● ensure safety, quality and success of project in Compliance with corporate strategies, SOP’s and ich/gcp ● inspection/audit Training, readiness and conduct, overall Compliance, capa assurance

  • Project employment ​as ​(Sr.) CRA and Clinical Projectmanager

    October 2002 --- January 2009

    international projectmanagement of Clinical studies Phase II, iii and iv ● development and writing of project plans, protocols and essential documents ● feasibility management and contracts ● develop study budget, Planning of resource, Training ● managing CRO’s and/or Clinical sites, ensuring and reporting overall timelines ● (co­)monitoring and review ● investigators and monitors meetings (organization and presentation) ● kol management and initiating and Planning/reviewing Investigator driven studies ● Expert team and brand team Member with Marketing and Sales ● cross development functionality ● ensure safety, quality and success of project in Compliance with corporate strategies, SOP’s and ich/gcp ● inspection/audit Training and readiness, capa handling

Personality

Self Assessment :
Analytical thinkingAssertivenessCreative thinking

Knowledge

Self Assessment :
Phase I R&DAdverse Events (AE)ApplicationsBiomedical SciencesBudgetsInformed Consent ProcessGood Clinical Practice (GCP)GMPEthics submission and approval processElectrocardiogram (ECG)Electronic Data Capture (EDC) Efficacy trialseCRFEarly development stageDrug Supply Management activitiesDrug Safety and PharmacovigilanceDrug development processCardiologyCAPAClinical Data ManagementClinical DevelopmentClinical monitoringClinical operationsClinical pharmacologyClinical researchClinical Study DesignClinical study reportsClinical SuppliesClinical trial audits and inspectionsClinical trial budgetingClinical trial designClinical trial managementClinical Trial Management System (CTMS)Clinical trials

Skills and Expertise

Self Assessment :
Interact with physicians Monitor a clinical study

Education

  • MSc in Biomedical Sciences from Leiden University in 2002

Languages

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

Area / Region

Leiden, Netherlands

Others

Driving License
  • Yes

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