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Summary

a project and team Leader with a wide range of experience in the project coordination, Software Development (using various waterfall, iterative and incremental development methodology such as rad, uml, rup and customer-specific) and Project Management (PRINCE2, agile and customer-specific) in large international environment. 
proven Leadership skills involving managing, developing and motivating teams to achieve their objectives. able to use own initiatives to achieve company objectives.
excellent computer, analytical (business and technical) and Documentation skill sets.
excellent design and Problem Solving skills. flexible, learns new tasks/skills quickly and ability to work autonomously.
expertise in .net technologies (asp.net, c#, SQL server, SharePoint)

Experiences

Past Experience

  • Business Analyst - Capacity Planning Rixensart

    January 2015 --- November 2017
    Analysis

  • Network-IT Project Manager Braine-L'Alleud

    May 2013 --- December 2014
    Project Management

  • Data Analyst Bruxelles

    November 2011 --- February 2013
    Inventory Management

  • Software Architect & Engineer Brussels

    January 2006 --- January 2013
    Adverse Events

  • Senior Clinical Software Designer Ottignies

    March 2011 --- October 2011
    Project Management

  • Data Governance Analyst Bruxelles

    November 2010 --- February 2011
    Data cleaning

  • Project Manager Zaventem

    February 2010 --- August 2010
    MS Project

  • Project Manager, GRSI (Global Regulatory Science Informatics) Braine-L'Alleud

    November 2008 --- November 2009
    business analyst

  • Manager, Clinical Data Coordination Rixensart

    November 2006 --- July 2008
    Data entry

  • Senior System/Business Analyst, Clinical Research Department Diegem, Brussels

    June 2004 --- November 2006
    Clinical Research Coordinator

  • Project Leader, Clinical Software Services Brussels

    January 2000 --- June 2004
    Data Management

  • Senior Developer Bruxelles

    January 1998 --- January 2000
    Data Management

Personality

BrightOwl Assessment :
Emotional reactivityOptimismCuriosityReaction to stressResiliencyCreative thinkingEfficiencyKindness

Knowledge

BrightOwl Assessment :
Design and tracking systemsIt skillsPhase IPhase IIPhase IIIPhase IVEfficacy trialsSafety trialsWriting Study Procedures and SOPsDatabase design and maintenanceData entryPhases of clinical development (phase I to IV)Understanding of regulatory guidelines
Self Assessment :
Drug development processPhases of clinical development (phase I to IV)Designing case report formsData entryRandomization and blindingICH GCP guidelinesInformed Consent ProcessDrug Safety and PharmacovigilancePatient Follow UpSafety trialsEfficacy trialsPhase IPhase IIPhase IIIPhase IVGood Clinical Practice (GCP)It skillsUnderstanding of regulatory guidelines

Skills and Expertise

BrightOwl Assessment :
Analyze data/information to determine potential relationships.assess the needs of the project(s)/program(s) and make changes in process, work flow and/or assignments.Collect data as required by the protocol and complete case report forms and reviews for completeness.Conduct limited data and/or statistical analysis.control different protocol versions and other essential documentsDesign the database Design, document, test, implement and manage clinical data collection and reporting systemsDevelop and maintain tracking systemsEdit dataInteract with computer specialistsInteract with information specialistsLiaise with research team in order to accurately collect and record dataperform Data codingperform Data validationperform data entryperform Data verificationTransfer dataWork with coordination and data management teams
Self Assessment :
Analyze data/information to determine potential relationships.attend Investigator meetings requiring travel and report pertinent information back to research team members.Attend seminars, courses and meetings within and outside the companyCapture pertinent data onto source documents (i.e., vital signs, adverse events, concomitant medications, etc.).Coach and provide guidance to clinical staff.collaborate in research projects at universitiesCollaborate with PI and institution to respond to any audit findings and implement-approved recommendations.Collect data as required by the protocol and complete case report forms and reviews for completeness.Conduct limited data and/or statistical analysis.Design a tracking systemDesign case record formsDesign the database Design, document, test, implement and manage clinical data collection and reporting systemsDevelop and maintain tracking systemsDirect co-workers to achieve resultEnsure consistency between the protocol and CRFInteract with computer specialistsInteract with information specialistsInteract with statisticiansInterface with CROs and other contractors with guidance in order to implement clinical trial programs efficientlyLiaise with research team in order to accurately collect and record dataOversee outsourced data management activitiesperform Data codingperform Data validationperform data entryTransfer dataUpdate Clinical Trials Management System (CTMS) Work with coordination and data management teams

Education

  • Computer Science in from ULB (Universite Libre de Bruxelles) in 1998

Training and Certification

  • Spirit & Tools for Managers in 2008 Training
  • InForm Development & Lifecycle Management in 2006 Training
  • Cell Therapy in 2005 Training
  • Inform Architect for CDA's-Building CRF's in 2004 Training
  • Upgrading Web Development Skills from ASP to ASP.NET in 2003 Training
  • VoiceXML 2.0 in 2003 Training
  • Distributed Application Development in 2000 Training
  • Basic Immunology Course in 2008 Certification
  • Medicinal product Dictionary in 2008 Certification
  • Business Analyst CTMS Training in 2006 Certification
  • InForm 4.5 Train the Trainer in 2006 Certification
  • Advanced PL/SQL Programming in 2005 Certification
  • Advanced Presentation Skill in 2005 Certification
  • eRT/eDM Systems in 2005 Certification
  • Siebel CTMS - CDC in 2005 Certification
  • Project Management Principle in 2004 Certification
  • ORACLE Database Administration in 2002 Certification
  • SAS SQL and SAS access in 2002 Certification
  • CORBA and Java Development in 1999 Certification

Languages

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

Work Preferences

  • Work From Home:
    No
  • Work Regime:
    BrightOwl freelancer :    40 Hours per week
  • International:
    No

Area / Region

Brussels

Others

Driving License
  • Yes

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