Clin Data Mgr I
**Job Overview**
Covance is currently looking to recruit experienced Project Data Managers for our Biometrics group. Candidates with significant prior...
**Job Overview** Covance is currently looking to recruit experienced Project Data Managers for our Biometrics group. Candidates with significant prior experience and a proven track record in delivering on projects will be considered for the Project Data Manager role. + Serve as the technicalleaderon alldatamanagement aspects forproject(s) includingstait-up,maintenance,andcompletionactivities. + Develop [Global]Data Management Plans and QualityManagement(QM)Plansthat willdeliveraccurate,timely,consistent,andquality clinicaldata. + Identify andimplementsolutions to project data managementissuesand concerns,includingproactivepreventionstrategies based on metrics andforecasts. + Coordinate andparticipate i n thedevelopment oftheclinicaldata modeland/ordatabasedesignandannotatetheCRF (eCFR) accordingto thesespecifications. _I_ monitoringconventions. + Interactand collaborate with otherprojectand specialtyteammembers (clinical,programming, statistics, CDMtechnicalsuppo1t,drug safety,etc.) tosupporttheset-up,maintenance, andclosureofthedata managementaspectsoftheprojecttoensure consistent, cohesive data handlingand quality. + Coordinate the development and testing of data management systems edit _I_ datavalidation checks) diagnostics) and speciallistings _I_ procedures usedas toolsforthedata reviewanddiscrepancymanagement activities. + Reviewdata acquisition conventions anddata reviewguidelines _I_ diagnosticspecifications consistent with the clinicaldata model,[statistical] analysis plans, and CRF (eCRF) completion + Serve asthe projectand clientliaisonincludingmanagement andprovisionofprojectspecificdata managementstatus, cycle time, andproductivity metrics. + Advanced planning and risk management for projects(issueescalation, resource management). + Assist with goal creation and performancereviewassessment fordatareview project staff. + Ensureproject staff aretrainedand adheretoproject-specific, global, standardizeddatamanagement processes. + Support achievement of project revenue and operatingmarginfor data management activitiestoagreedtargets. + Identifyareas forprocessand efficiencyimprovementandimplementsolutions on assigned projects. + Maintaintechnicaldatamanagementcompetencies via pa1ticipationininternal and external training seminars. + Overseethe technicalpe1formance ofthe data reviewprojectstaff on achieving client satisfaction through delivery ofquality data,on-time and on-budget. + Developand maintain strategic clientrelationshipsandreceiveclientsatisfactionsurveysandimplementappropriate action plans asnecessary. + Supportbusinessdevelopment fordata managementtime and cost estimates andprepareand presenttopotentialclientson globaldatamanagement capabilities. + Performother duties as assigned bymanagement. + Reviewliteratureandresearchtechnologies/procedures forimprovingglobaldatamanagementpractices. REQUIREMENTS: + University/collegedegree(lifescience,pharmacyorrelatedsubjectpreferred),or certification + In a relatedalliedhealthprofession from an appropriately accredited institution (e.g., nursingcertification,medicalor laboratory technology). + Additional relevant workexperiencewill beconsideredinlieuof formalqualifications. + Broad knowledge of drug development processes. + Understanding of globalclinicaldevelopmentbudgets andrelationshipto productivity targets. + Knowledge of effectiveclinicaldata management practices. + Knowledgeof timeandcost estimatedevelopmentandpricing strategies. + Thorough knowledgeofTCHGuidelinesandGCPincludinginternational regulatoryrequirements for theconductof clinical development programs,especially asrelated to datahandlingandprocessing + Relevant workexperiencein data managementwithtechnicalsupervisoryexperiencetoinclude datamanagement,clinicaloperations,andknowledgeof severaltherapeuticareas. + Demonstratedskillsfortechnicalmanagement of staffexceeding5employees. + Financialmanagementof grossrevenues + Excellentoraland writtencommunication andpresentationskills. + In depthknowledge ofclinicaltrialprocess anddatamanagement,clinicaloperations,biometrics,qualitymanagement,andsystemsapplications tosupportoperations. + Workingknowledgeof therelationshipand regulatoryobligationof theCROindustry withpharmaceutical _I_ biotechnologicalcompanies. + Ability to lead byexampleteams on project strategies and achievement of departmentgoals,objectives,andinitiatives andtoencourage team members to seeksolutions. + Demonstratedmanagerialandinterpersonalskills **Education / Qualifications** + University/collegedegree(lifescience,pharmacyorrelatedsubjectpreferred),or certification + in a relatedalliedhealthprofession from an appropriately accredited institution (e.g., nursingcertification,medicalor laboratory technology). + Additional relevant workexperiencewill beconsideredinlieuof formalqualifications. + Broad knowledge of drug development processes. + Understanding of globalclinicaldevelopmentbudgets andrelationshipto productivity targets. + Knowledge of effectiveclinicaldata management practices. + Knowledgeof timeandcost estimatedevelopmentandpricing strategies. Thorough knowledgeofTCHGuidelinesandGCPincludinginternational regulatoryrequirements for theconductof clinical development programs,especially asrelated to datahandlingandprocessing **Experience** + Minimumfive (5)yearsrelevant workexperiencein data managementwithapproximatelyone( **1** **)** yeartechnicalsupervisoryexperiencetoinclude datamanagement,clinicaloperations,andknowledgeof severaltherapeuticareas. + Demonstratedskillfortechnicalmanagement of staffexceeding5employees. + Financialmanagementof grossrevenuesinexcessof$250Kperyear. + Excellentoraland writtencommunication andpresentationskills. + In depthknowledge ofclinicaltrialprocess anddatamanagement,clinicaloperations,biometrics,qualitymanagement,andsystemsapplications tosupportoperations. + Workingknowledgeof therelationshipand regulatoryobligationof theCROindustry withpharmaceutical _I_ biotechnologicalcompanies. + Ability to lead byexampleteams on project strategies and achievement of depa11mentgoals,objectives,andinitiatives andtoencourage team members to seeksolutions. + Demonstratedmanagerialandinterpersonalskills **Job Number** _2019-27614_ **Job Category** _Clinical Data Management_ **Position Type** _Full-Time_ Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). 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