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Experiences

Current Experience

  • Clinical Trial Assistant (CTA)


    Since November 2008
    work in collaboration with the global study manager by providing administrative and operational support to the Clinical studies/process; preparation of study file; preparation of submission package to ec and ca; give support/ad hoc attendance to meetings, prepare meeting materials; creation of studies in Clinical project tracking system and up-date the system; track day to day, in a proactive and autonomous manner, all essential documents; part of the ind taskforce, give ind Training and support; primary contact with the central Lab for inconsistency of information and data; primary contact for CRO countries and give support for submissions; train newcomers on different tracking systems, filling and ind; development and implementation of e-tmf filling system etmf Expert , provide Training ans support in wow development and implementation migration of paper file into etmf ( project plan and work flows ) primary contact for CRO company responsible for qc control on essential study documents quality check on study filing Work in collaboration with the Global Study Manager by providing administrative and operational support to the clinical studies/process; Preparation of study file; Preparation of submission package to EC and CA; Give support/ad hoc attendance to meetings, prepare meeting materials; Creation of studies in Clinical Project Tracking System and up-date the system; Track day to day, in a proactive and autonomous manner, all essential documents; Part of the IND taskforce, give IND training and support; Primary contact with the central Lab for inconsistency of information and data; Primary contact for CRO countries and give support for submissions; Train newcomers on different Tracking Systems, Filling and IND; Development and implementation of e-TMF filling system eTMF expert , provide training ans support in WoW Development and implementation migration of paper file into eTMF ( project plan and work flows ) Primary contact for CRO Company responsible for QC control on Essential Study documents Quality check on study filing

Past Experience

  • Qa

    June 2003 --- October 2008
    visually verify all manually entered information on Clinical data, all cardiologists’ interpretations to Clinical data where appropriate, all entered values in the supplemental Databases; review Clinical data for consistency of information; document any necessary changes in Clinical data and notify the appropriate department of any update needed; assist in performing the final qa check of Pharmaceutical data submissions; knowledgeable of Quality Assurance SOP’s, computer network and timeline importance check Software validations, load specifications, Validation protocols and test reports assist in performing qa check of study files or Databases of external companies and vendors according to ich/gcp. writing of qc reports according to ich/gcp. other duties as deemed necessary to ensure high quality service.

  • QA Technician - ABP operator

    June 2003 --- September 2008
    visually verify all manually entered information on Clinical data, all cardiologists’ interpretations to Clinical data where appropriate, all entered values in the supplemental Databases; review Clinical data for consistency of information; document any necessary changes in Clinical data and notify the appropriate department of any update needed; assist in performing the final qa check of Pharmaceutical data submissions; knowledgeable of Quality Assurance SOP’s, computer network and timeline importance check Software validations, load specifications, Validation protocols and test reports assist in performing qa check of study files or Databases of external companies and vendors according to ich/gcp. writing of qc reports according to ich/gcp. other duties as deemed necessary to ensure high quality service. receiving data transmissions by telephone; reviewing data for completeness and exclusivity criteria, data for consistency; distribute and file the abp reports, making changes to the database; verify and document any changes to the data due to discrepancies, notify the Investigator of data discrepancies.

Knowledge

LinkedIn Assessment :
Computer System ValidationClinical Data ManagementPharmaceutical IndustryClinical trialsClinical DevelopmentGCPSOPRegulatory affairsRegulatory submissionsCROValidationGMPCTMSICH-GCP21 CFR Part 11FDAoncologyPharmacovigilanceBiotechnologyEDC

Skills and Expertise

Self Assessment :
Guide students Report data Use content management systemsAdminister supply requestAdministrative supportAdverse event reportingArchive documentationArchive study documentsAssess site feasibilityBuild trial master file (TMF)Clinical data collectionCollaborate with project teamCollect dataCommunicate with sponsorComplete case report form (CRF)Complete study proceduresControl protocol versionsCoordinate ethics committeeCreate clinical documentsCreate study documentsDesign trial master file (TMF)Distribute study documentsDocument data collection systemEnsure good clinical practice (GCP)Follow-up of quality assurance activitiesGenerate regulatory submissions Handle callsInformed consent processManage clinical trial files/documentsManage Clinical Trial Management System (CTMS) Organise meetingsOral presentationProvide trainingProvide study site fileQuality control processRetrieve study documentsReview exclusion criteriaReview inclusion criteriaReview informed consent processReview monitoring reportsReview protocolsReview quality control activitiesReview study protocolsSolve problemsUnderstand protocolsWork under specific instructionsWritten presentation

Education

  • in from BioPharE in 2015
  • in from Xpepharma in 2014
  • High school in Educator Spacial youth work from Sancta Maria Leuven in 1997
  • ASO in from H.Hart Heverlee in 1993

Training and Certification

  • ICH-GCP in 2015 Training
  • Project management in 2014 Training
  • CRA training in 2015 Certification

Languages

BrightOwl Assessment:
Self Assessment:
Dutch
Native
English
Full Proficiency
French
Professional Proficiency

Area / Region

Leuven, Belgium

Others

Driving License
  • Yes

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