proven Sales and Marketing experience as well as: Clinical introduction support and development, Research and data gathering and it's management through Training, experience, perseverance and fortitude. • Clinical Project Manager in a wide variety of business Applications. • experienced hands-on Product Development skills. • interested in early-stage startups as well as companies “on the bubble.” • Training and introduction experience in the Medical Device market. • expanding Clinical Applications and indications for use. • intermediate between the Clinical arena and the Product Development team. • international experience with the different languages and cultures en Sales en Marketing specialties: Training, introduction of new devices on the market, clinically support the new device introduction, pick up ‘the good the bad and the ugly’ from the Clinical arena and translate that to the device development team. clinically support the hands-on Training of the operator and the Hospital staff. organization of registries and randomized trials. ISO and ce registration. setting up a worldwide distribution and Sales agent network
Clinical Field EngineerEMEA
Since November 2016
participate in all aspects of the conduct of Clinical trials at assigned
sites and support the enrolment at specific clinical sites.
data collection during Clinical Trial procedures
generate and maintain working relations with the investigators and the Research staff at the clinical sites.
assist in the management of the of the clinical site monitoring plans and procedures.
assist in maintaining clinical site Compliance.
serve as Clinical Trial and the science)" rel="nofollow">Protocol Expert, ensuring each site’s science)" rel="nofollow">Protocol Compliance.
consistently promote collaboration positivity, accountability, and resourcefulness.
work closely with the departmental personnel on the status of the of assigned sites for all Clinical trials.
oversee and or conduct site initiation and staff and Investigator Training.
provide feedback to management on the ongoing, progress of assigned site for all Clinical trials
Participate in all aspects of the conduct of clinical trials at assigned
sites and support the enrolment at specific clinical sites.
Data collection during clinical trial procedures
Generate and maintain working relations with the investigators and the research staff at the clinical sites.
Assist in the management of the of the clinical site monitoring plans and procedures.
Assist in maintaining clinical site compliance.
Serve as clinical trial and the protocol expert, ensuring each site’s protocol compliance.
Consistently promote collaboration positivity, accountability, and resourcefulness.
Work closely with the departmental personnel on the status of the of assigned sites for all clinical trials.
Oversee and or conduct site initiation and staff and investigator training.
Provide feedback to management on the ongoing, progress of assigned site for all clinical trials
Since December 2012
alja lambers and hand meulenbrug founded the company in 2012. due to their experience over the past 20 years they developed a fast network of professionals. core business: Clinical Sales and Marketing, investment, support and develop new modalities, products and ideas to market
Alja Lambers and Hand Meulenbrug founded the company in 2012. Due to their experience over the past 20 years they developed a fast network of professionals. core business: Clinical sales and marketing, investment, support and develop new modalities, products and ideas to market
CEO/General ManagerApril 2003 --- July 2015
comed bv is a medical Consulting company and was founded in 2003. on average we take care of 8 to 12 projects. we work on a contract bases as well as on project based assignments. every year we doubled our overall Sales. we consult for american, european as well as for chinese companies. we support everything that needs to be done from the drawing board unto the availability of the product on the Hospital shelf. we started off working for small startup companies so we are used to pick things up and to go with it. from 2003 until the end of 2006 i took care of the Clinical support for stereotaxis. Clinical Sales and Marketing, system introduction, Training and Clinical support.hands on Research and data gathering on different Applications and indications.
Clinical DirectorFebruary 2002 --- February 2003
Clinical DirectorJanuary 2000 --- September 2002
managed the european Clinical department set up a registry for both the Cardiology- and the peripheral application. organized bi-monthly Clinical specialist Training meetings co-finalized the Training manual. distributor support and Training system introduction and installation in europe Clinical Sales and Marketing and Research, Clinical system introduction and Training and Clinical support during patient treatments.
Clinical Training Manager EuropeDecember 1997 --- January 2000
setup a distributor network throughout europe. introduced iptd and the perducer device in the european market. managed the distributor network and organized a Training update meeting every 6 months at the distributor’s site. participated in the introduction and Training of the operators the Hospital staff as well as the distributors in the different markets. participated in the actual Treatment of 120 pigs in a combined trial with introgene in leuven. worked with my american counterpart on the development of a registry and participated in a mini trial in marburg. Clinical adoption and application devellopment, Clinical Sales and system introduction, hands on Clinical support during patient treatments, Clinical hands on during Research and Treatment.
Clinical Manager EuropeJanuary 1995 --- January 1997
introduction of four different stents. the registration of these stents in the different countries. build a distribution network in europe. build a network of Sales and Marketing organization in europe. managed 12 distribution companies in different countries. setting up and helping to run a multicenter randomized trial. direct instruction and Training medical and paramedical staff. assisting an instructing and Training during patient treatments. co writing and assembly of Training documents Clinical Sales and Marketing and Research. worldwide Clinical system introduction and Clinical support during patient treatments
Clinical Specialist Europe Middle East and SAJanuary 1990 --- July 1995
introduced rotational artherectomie in the described markets. system introduction theoretical as well as hands on Training operators, Hospital staff and distributors. managed 21 distributors in the region. took care of the british market; Sales& Marketing as well as clinically for 6 months. organized every 6 months Clinical meetings at the distributors organization. participated in the setup of the european registry and participated in the new product developments team. system introduction to the interventional market worldwide. Clinical Sales and Marketing and Research. hands on Clinical support during patient treatments, about 2000 patients in total.
Nurse IC ICUMarch 1986 --- September 1990
General NurseSeptember 1981 --- February 1986
Service orientedAssertivenessImpulse commandAnger commandApproachabilityPerspectiveProblem solvingAnalytical thinkingDependabilityOrganizationAuthenticityCreative thinkingInterest in knowledgeCuriosity
SociabilityTrustStrategic thinkingSelf-disciplineOrientationCuriosityCompetitivenessIndividualityCreative thinkingCollaborationCharmAuthenticityAttention to detailAssertivenessApproachabilityAnalytical thinkingCritical thinkingCoordinationProblem solvingKindnessOrganizationOptimismInterest in knowledgeIndependenceInnovative thinkingEfficiencyAdaptability
Medical Devices R&DCardiologyHospitalspeople managementProblem-solving methods and troubleshootingProduct designProject ManagementPulmonary diseasesRespiratoryTeam Leadership NegotiationPatient Screening and RecruitmentProcess improvement
Animal models Diabetes Medical devices Negotiation Phase I R&D Scientific writingAnesthesiaAnimal trialAnimal ModelsCardiologyCardiovascular diseasesClinical Data Management (CDM)Clinical DevelopmentClinical monitoringClinical operationsClinical researchClinical Study DesignClinical trial audits and inspectionsClinical trial budgetingClinical trial designClinical trial managementClinical trialsContract negotiationData ManagementData entryData AnalysisDesigning case report formsDiagnostic radiologyEnglishEthics submission and approval processFDAGermanGood Clinical Practice (GCP)HospitalsHuman ResourcesKOL managementManaging Clinical Trial SuppliesMarket accessMedical affairsMedical budget managementMedical consultingMedical DevicesMedical writingMicrosoft ExcelMicrosoft OfficeMonitoring Study ProgressNegotiationpeople managementPhases of clinical development (phase I to IV)PowerPointPrinciples and ethics of clinical researchProduct launchProject ManagementProtocolPulmonary diseasesR&DRegistration of the productWriting Study Procedures and SOPsInformed Consent DocumentsUnderstanding of regulatory guidelinesThoracic surgeryTechnical reportsTeam LeadershipSupervising CRAsRegulatory affairsQuality Assurance (QA)Product designPre-clinical researchPreclinical regulations and practicesPatient Screening and Recruitment
Skills and Expertise
Interact with nurses Interact with physicians Interpret data Search literature on clinical trials Technology researchAdjust methodsAdjust processes Adjust processes and methodsAdvise on medical perspectivesAssist with proceduresAssist with routine testsAssure medical qualityCoachCoach clinical staffCoach staffCollaborate with medical teamCollaborate with project teamConduct literature searchesCreates a collaborative team environmentDirect co-workersExecute scientific projectsGuide staffInteract with physiciansInterpret dataLiaise with doctorsLiaise with research teamlifescienceNegotiationNetworkProvide input to process improvement initiativesRead medical literatureSolve problemsTrain on site staff
Monitoring enrolmentLiaise with doctorsInterpret dataInteract with pre-clinical scientistsInteract with physiciansInteract with nursesInteract with ethics committeeInteract with CROsInformed consent processIdentify investigatorsLiaise with research teamIndentify sitesMonitor dataMonitor clinical trials Monitor a clinical studyManuscript preparation and reviewManage study budgetManage projects resourcesManage contractors Manage Clinical Trial Management System (CTMS) Manage clinical trial files/documentsIndentify clinicians to conduct clinical trialsImplement data collection systemEnsure data consistencyDocument data reporting systemsDocument data collection systemDocument adverse eventsDistribute trial suppliesDistribute study documentsDiscuss treatments with investigatorDirect co-workersDevelop study timelinesEnsure data integrityEnsure good clinical practice (GCP)Handle callsGuide staffFacilitate sponsor monitoring visitsExtrapolate dataExecute scientific projectsEvaluate protocolsEthics committee submissionsEthics committee applicationEstimate subject complianceDevelop study budgetMonitoring subject complianceScreen patientsValidate dataWrite medical reportsWrite papersWritten presentationReview study protocolsReview monitoring reportsReview exclusion criteriaReview inclusion criteriaReview medical reportsTrain on site staffTrain off site staffSelect contractors Select investigatorsSet up a clinical studySite managementSolve problemsSupervise clinical monitorsSupervise data processingSupervise techniciansSupervise trial suppliesResearch at universitiesReport serious adverse events (SAE)Patient liaisonParticipate in medical reviewOrganise steering committeeOrganise meetingsOral presentationOffice managementNegotiationNegotiate protocol details Negotiate payment schedulesPatient recruitmentPersuade clinicians to conduct clinical trialsRead medical literaturePublish scientific projectsPublication of articlesProvide trainingProtocol managementPromotional materialsPresent clinical resultsPresent data at congressPlanning clinical studiesNegotiate budget Develop regulatory strategyComplete case report form (CRF)Attend steering committeeAttend seminarsAttend investigator meetingAssure medical qualityAssist with routine testsAssist with experimentsAssist with proceduresAssist study siteAssign activitiesClinical data collectionCoachCommunicate with sponsorCommunicate with investigatorCollect patient forms and questionnairesCollect financial data from hospitalsCollaborate with project teamCollaborate with principal investigatorCollaborate with medical teamCoach staffCoach clinical staffAssess subject safetyAssess site feasibility Report data Monitor a clinical study Interpret data Interact with physicians Interact with nurses Guide students Develop protocols Develop clinical trial protocols Design case record forms Search literature on clinical trials Technology researchAssess adverse reactionsArchive documentationApprove queriesApprove patient informationApprove monitoring reportsApprove consent documentsAnalyze dataAdvise on medical perspectives Write papers Assure medical qualityComplete study proceduresDevelop clinical trial protocolsDesign information leafletDesign inclusion criteriaDesign exclusion criteriaDesign data reporting systemsDesign data collection systemsDesign Clinical Trial Management System (CTMS) Design clinical trialDesign case record form (CRF)Data validationDesign marketing advertismentsDesign post-marketing surveillance studyDevelop clinical strategyDevelop clinical hypothesesDetermine potential relationshipsDesign trial master file (TMF)Design tracking systemDesign subject consent formDesign study documentsDesign studyDesign protocolData verificationData entryContact potential subjectsConfirm protocol complianceConduct university research Conduct the trialConduct site initiationConduct research at universitiesConduct post-marketing surveillance studyConduct monitor visitsConduct literature searchesContract approvalCoordinate ethics committeeCreate study documentsCreate standard operating procedure (SOP)Create SOPsCreate economic parametersCreate clinical documentscoordinating research projectsCoordinate with the ethics commiteeCoordinate regular advisory boardCoordinate logisticsConduct close-out visits
in Marketing from NIMA-A in 1995
RN in Intensive care Coronary care from Fontys Hogescholen in 1988
RN in General nursing from Nursing School Eindhoven in 1984
Bachelor of Science (BSc) in from Osteopathie College Sutherland in 0000
Training and Certification
NIMA A in 2003 Certification
Expert has 3 publications (Will be avalible with full profile)