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Experiences

Past Experience

  • Clinical Research Scientist - Medical Imaging Germany

    September 2008 --- March 2016

    lundbeck a/s, Neurology department

    (denemark and germany)

     

    • management of multinational Clinical Trial (Phase I to Phase III) in Compliance with GXP and international conference on harmonisation (ich-gcp)
    • Technical Support to research and development projects (Phase I to Phase IV)
    • decision making on sites’ imaging Qualification (based on feasibility questionnaires or on-site)
    • preparation of imaging protocols for almost all available ct and MRI scanners
    • analyses of imaging, Lab and ecg data from clinical sites
    • Planning and management of centralised study imaging procedures (i.e. with central readers and central imaging labs)
    • budget responsibility
    • clinical sites’ visits
    • support of other departments, such as bio-Statistics, Data Management, pre-clinical, Medical writing, Pharmacovigilance, when it comes to finalization of study reports, Data cleaning/reconciliation, query issuing, medical monitoring or preparation of study database close
    • contribution and input to regulatory strategies
    • close cooperation with sites, Clinical Research Associates (cras) and external contract research organisations (cros)
    • decision making in the selection of imaging laboratories (main contributor)
    • contribution to studies headline results and results analyses of pooled analyses across trials
    • preparation of Training material for study sites

     

    • authorship and approval of study documents

     

    • study science)" rel="nofollow">Protocol, imaging manual, imaging charter, study management plan, monitoring manual and sops

     

    • information management and Training of study investigators (e.g. radiologists and neurologists)
    • discussion of study neuro-imaging protocols
    • discussion of study technical and safety requirements
    • worldwide installation of study imaging Software
    • setting of imaging devices at clinical sites
    • clinical sites’ Training on neuro-imaging

     

     

    • participation to Due Diligence activities
    • public affairs and stakeholder Communication
    • speaker at international scientific meetings
    • organisation and management of workshops and seminars
    • involvement and participation to study Publications in the Neurology department

     

  • Imaging Specialist - Medical Imaging (e.g. Stroke and other indications)

    January 2005 --- August 2008
    • technical and imaging advice for paion international Clinical trials
    • decision making on imaging protocols, transmittal forms, sequences and contrast agents to be used in paion’s Clinical trials
    • decision making on sites’ imaging Qualification (i.e. availability of scanners, sequences and qualified personnel)
    • evaluations of new surrogate imaging marker for paion’s investigational drugs
    • close cooperation with radiologists and neuro-radiologists
    • Planning, organisation and management of the centralised imaging procedures (i.e. with central readers and central labs)
    • presentation of the company products at several congresses and meeting
    • imaging support of clinical sites
    • cooperation with key opinion leaders (kols)
    • Analysis of trials imaging data (e.g. ct, MRI, pet and ultrasound
    • analyses of ecg and Lab data
    • database cleaning and reconciliation
    • generation of sites queries, dcfs and drfs
    • close cooperation with sites Clinical Research Associates (cras)
    • representation of the company at several investigators’ meetings
    • budget responsibility
    • close cooperation with the medical products managers at paion
    • selection of Software and Algorithms to be used in the post-processing of raw images from trial sites

  • Medical Technician

    September 2003 --- December 2004
    • running of MRI trials and Analysis of images
    • setting and operating MRI scanners
    • administrative preparation MRI trials
    • development of MRI sequences (e.g. volumetric MRI, functional MRI and mr Spectroscopy)

  • Practical Training and student assistant

    November 2001 --- May 2002
    • conception and building of magnetic resonance imaging coils

Knowledge

LinkedIn Assessment :
MRIMedical ImagingClinical trialsDigital ImagingRadiologyfMRIClinical researchComputed Tomography CTCardiologyNeurosciencestrokeClinical DevelopmentPharmaceutical IndustryGCPCRONeurologyCRO

Skills and Expertise

Self Assessment :
Analytical skills Assure medical quality Build and manage the Trial Master File (TMF) Control data Create SOPs Design case record forms Develop clinical trial protocols Develop protocols Guide students Interact with nurses Interact with physicians Interpret data Monitor a clinical study Report data Search literature on clinical trials Technology research Write papers Write protocolsAct as the main line of communication between the sponsor and the investigatorAdjust processes Adverse event reportingAdvise on medical perspectivesAdvise on strategyAlzheimerApprove monitoring reportsApprove patient informationApprove queriesApprove suitability of patient information and consent documentsArchive study documentsArchive trial documentation and correspondence.Assess adverse reactionsAssess site feasibilityAssess subject safetyAssess quality process issuesAssist study siteAssist with site trainingAttend at steering committee meetingsAttend investigator meetingAttend seminarsAttend seminars, courses and meetings within and outside the companyAttend steering committeeBiomarker ResearchBuild trial master file (TMF)Capture data on source documentsClinical data collectionCoach clinical staffcollaborate in research projects at universitiesCollaborate with medical teamCollaborate with PI and institution to respond to any audit findings and implement-approved recommendations.Collaborate with principal investigatorCollaborate with project teamCollect dataCollect patient forms and questionnairesCommunicate effectively on different company levelsCommunicate with investigatorCommunicate with sponsorCommunicationComplete case report form (CRF)Complete study proceduresConduct animal studiesConduct close-out visitsConduct literature searchesConduct literature searches.Conduct research at universitiesConduct site initiationConduct studiesContract approvalContribute medical, clinical expertise and scientific advice to all allied departments in local affiliate in particular support to the local clinical development team for timely execution of studies conducted in the affiliate and to DRA in interactions with authorities.Create clinical documentsCreate clinical project documents according to the protocolCreate standard operating procedure (SOP)Create study documentsData entryData validationData verificationDesign clinical trialDesign exclusion criteriaDesign inclusion criteriaEthics committee submissionsEthics committee applicationEnsure data consistencyEnsure data integrityEnsure consistency between the protocol and CRFEstablish relationships with Key Opinion LeadersEstablish professional relationships with partnersEvaluate licensing opportunitiesEvaluate protocolsEvaluate stability data Execute scientific projectsFeasibility analysis of proposed trial designFollow-up of external auditsFollow-up of internal auditsFollow up training programsIdentify investigatorsInformed consent processInteract with computer specialistsInteract with CROsInteract with ethics committeeInteract with KOLInteract with nursesInteract with pharmacistsInteract with physiciansInteract with pre-clinical scientistsInteract with regulatory stakeholdersInteract with statisticiansInterpret analytical resultsInterpret dataInterpret research resultsInterpret scientific dataLabeling compliance with local regulationsLiaise with doctorsLiaise with doctors and other professionals throughout the studyLiaise with professionals in other divisions of the company as requiredLiaise with research teamLiaise with research team in order to accurately collect and record datalifescienceMaintenance of biomedical equipmentManage budgetsManage clinical trial files/documentsManage contractors Manage data collection systemManage data reporting systemsManage global quality standardsManage multiple projectsManage publication strategy of clinical trial resultsManage subject consent formManage subject safetyManage trial master file (TMF)Manage vendor budgetsmanaging a small teamMonitor dataNegotiate payment schedulesNegotiationNetworkOperate research equipmentOral presentationOrganise meetingsOrganise steering committeeParticipate in medical reviewPatient recruitmentPersuade clinicians to conduct clinical trialsPlan work to meet objectives and deadlinesPlanning clinical studiesPresent at steering committeePresent clinical resultsPresent data at congressProvide medical rationale of diseaseProvide medical insightsProvide technical supportProvide trainingPublication of articlesR&DRead medical literatureRead medical literature to maintain current awareness and knowledgeReport serious adverse events (SAE)Report technical problemsResolves queriesRespond to audit findingsReview clinical study reportsReview exclusion criteriaReview inclusion criteriaReview informed consent processReview medical reportsReview monitoring reportsReview protocolsReview queriesReview study protocolsReview the interpretation of dataReview vendor metricsReview vendor reportsSchedule trial visitsSchedule sponsor monitoring visitsScheduling trial visitsSearch literature on clinical trialsSelect contractors Select investigatorsSelect sitesSerious Adverse Event (SAE) ReconciliationSetup of research equipmentSite managementSolve problemsStudy-related documentsSupervise clinical monitorsTrain off site staffTrain on site staffTrain StaffUnderstand protocolsUpdate Clinical Trials Management System (CTMS) Verify dataWork cross-functionallyWork with coordination and data management teamsWrite documentsWrite final reportsWritten presentation

Education

  • Engineer in Biomedical Engineering from Fachhochschule Aachen in 2003

Languages

BrightOwl Assessment:
Self Assessment:
German
Full Proficiency
Arabic
Native
French
Full Proficiency
English
Full Proficiency

Publications

    Expert has 2 publications (Will be avalible with full profile)

Area / Region

Germany

Others

Driving License
  • Yes

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