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Summary

t!write offers a variety of Clinical research services for Pharmaceutical Industry, CRO’s, biotech companies and research sites ranging from overall study coordination (Project Management), Data Management, Data Analysis to medical and Report Writing. we design, manage and analyze studies in a wide range of Therapeutic Areas in all phases of Clinical trials. t!write is specialized in Medical Device trials in Orthopedics and the cardiovascular and endovascular field. our goal is to provide Expert consultation in a timely fashion. we make sure that your documents are conform the regulations, your studies are conducted following the ich-gcp / ISO 14155 guidelines and your data are correctly presented. if you are interested to know more about our company and expertise, or discuss how we may assist you in providing solutions for your problems, then contact us: tine willems, phd vaartstraat 78 9270 kalken belgium +32 499 75 79 08 www.twrite.be

Experiences

Current Experience

  • Founder

    Kalken
    Since March 2010

    t!write offers a variety of Clinical research services for Pharmaceutical Industry, CRO’s, biotech companies and research sites ranging from overall study coordination (Project Management), Data Management, Data Analysis to medical and Report Writing. we design, manage and analyze studies in a wide range of Therapeutic Areas in all phases of Clinical trials. t!write is specialized in Medical Device trials in orthopaedics and the cardiovascular and endovascular field. our goal is to provide Expert consultation in a timely fashion. we make sure that your documents are conform the regulations, your studies are conducted following the ich-gcp / ISO 14155 guidelines and your data are correctly presented.

    T!Write offers a variety of clinical research services for pharmaceutical industry, CRO’s, biotech companies and research sites ranging from overall study coordination (project management), data management, data analysis to medical and report writing. We design, manage and analyze studies in a wide range of therapeutic areas in all phases of clinical trials. T!Write is specialized in medical device trials in orthopaedics and the cardiovascular and endovascular field. Our goal is to provide expert consultation in a timely fashion. We make sure that your documents are conform the regulations, your studies are conducted following the ICH-GCP / ISO 14155 guidelines and your data are correctly presented.

  • Post-doctoral researcher - coordinator Orthopride


    Since March 2010

Past Experience

  • Core lab data manager

    August 2007 --- February 2010

  • Clinical Research Associate (CRA)

    September 2006 --- August 2007

  • Postdoctoral reseacher at Ghent University

    January 2005 --- January 2006

Personality

Self Assessment :
IndependenceCreative thinkingTrustOrganizationEfficiencyInterest in knowledgeAttention to detail

Knowledge

Self Assessment :
Cardiovascular diseasesOrthopedic surgeryPhysical medicine and rehabilitationSports medicineVascular surgeryUnderstand levels of research evidenceSearch literature on clinical trialsInterpret clinical trial resultsInterpret systematic reviewsClinical trial designRandomization and blindingStudy outcomes and outcome measuresDeveloping Clinical Trial ProtocolsDesigning case report formsDatabase design and maintenanceStatistical considerations in design and analysisData entryPrinciples and ethics of clinical researchEthics submission and approval processInformed Consent DocumentsProject ManagementInformed Consent ProcessMonitoring Study ProgressICH GCP guidelinesWriting Study Procedures and SOPsGood Clinical Practice (GCP)Scientific methodologySafety trialsEfficacy trialsData ManagementClinical Data Management (CDM)OrthopedicscienceHealthcare industryICH-GCP
LinkedIn Assessment :
Clinical trialsClinical researchMedical DevicesLifesciencesClinical DevelopmentElectronic Data Capture (EDC) BiotechnologyCROGCPPharmaceutical IndustryMedical writingCardiologyscienceData Management

Skills and Expertise

Self Assessment :
Act as the main line of communication between the sponsor and the investigatorAnalyze data/information to determine potential relationships.Approve suitability of patient information and consent documentsAssign, coordinate and supervise day-to-day activities of clinical study monitorsAttend at steering committee meetingsDesign the studyWrite protocolsWrite final medical reports based on the physician's evaluationWrite combined statistical and medical reportswrite an understandable and appropriate subject consent form and information leafletWork with the PI to manage the day-to-day activities of the study including problem solving and protocol management.Work with coordination and data management teamsPrepare medical reportscollaborate in research projects at universitiesCoach and provide guidance to clinical staff.Conduct research at universitiesCoordinate with the ethics committeeCreate clinical project documents according to the protocolDesign case record formsCreate Standard Operating Procedures for each study or clinical trial.Develop protocolsEnsure consistency between the protocol and CRFgenerate Clinical Trial Report and manuscript for publicationInitiate clinical trials Interpret dataLiaise with doctors and other professionals throughout the studyMaintain and manage internal clinical trial files and documentsprepare study-related documentation; put together a succesful ethics committee application

Education

  • doctor in life science in Sports injuries, biomechanics from Ghent University in 2004
  • master in physical therapy from Universiteit Gent in 2000

Work Preferences

  • Work From Home:
    No
  • Work Regime:
    BrightOwl freelancer
  • International:
    Yes

Area / Region

Kalken

Others

Driving License
  • Yes

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