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Trabajo : Clin Data Mgr I:

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Trabajo :
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   » Company:
Covance
   » Location:
Portugal, Lisbon
   » Salary:
negotiable / month
   » Job type:
Full-Time
   » Posted:
6 mins ago
   » Category:
General

**Job Overview**
Covance is seeking a Clinical Data Manager to work within their Late Phase Data Management Department. You willserve as the technicalleaderon alldatamanagement aspects forproject(s) includingstart-up,maintenance,andcompletionactivities.
This role is permanent full time, office or homebased in the UK, Germany, Italy, Spain or Portugal.
Responsibilities/Duties:
+ Serve as the technicalleaderon alldatamanagement aspects forproject(s) includingstart-up,maintenance,andcompletion activities.
+ Develop [Global]Data Management Plans and QualityManagement(QM)Plansthat willdeliveraccurate,timely,consistent,andquality clinical data.
+ Identify andimplementsolutions to project data managementissuesand concerns,includingproactivepreventionstrategies based on metrics and forecasts.
+ Serve asthe projectand clientliaisonincludingmanagement andprovisionofprojectspecificdata managementstatus, cycle time, andproductivity metrics.
+ Coordinate andparticipate in thedevelopment oftheclinicaldata model and/ordatabasedesignandannotatetheCRF (eCRF) accordingto these specifications.
+ Reviewdata acquisition conventions anddata reviewguidelines _I_ diagnosticspecifications consistent with the clinicaldata model,[statistical] analysis plans, and CRF (eCRF) completionmonitoring conventions.
+ Coordinate the development and testing of data management systems edit _I_ datavalidation checks) diagnostics) and speciallistings _I_ procedures usedas toolsforthedata reviewanddiscrepancymanagement activities.
+ Interactand collaborate with otherprojectand specialityteammembers (clinical,programming, statistics, CDMtechnicalsupport,drug safety,) tosupporttheset-up,maintenance, andclosureofthedata managementaspectsoftheprojecttoensure consistent, cohesive data handlingand quality.
+ Advanced planning and risk management for projects(issueescalation, resource management).
+ Overseethe technicalperformance ofthe data reviewprojectstaff on achieving client satisfaction through delivery ofquality data,on-time and on-budget.
+ Assist with goal creation and performancereview assessment fordatareview project staff.
+ Maintaintechnicaldatamanagementcompetencies via participationininternal and external training seminars.
+ Ensureproject staffs aretrainedand adheretoproject-specific, global, standardizeddatamanagement processes.
+ Identifyareas forprocessand efficiencyimprovementandimplementsolutions on assigned projects.
+ Support achievement of project revenue and operatingmarginfor data management activitiestoagreedtargets.
+ Developand maintain strategic clientrelationshipsandreceiveclientsatisfactionsurveysandimplementappropria te action plans as necessary.
+ Supportbusinessdevelopment fordata managementtime and cost estimates andprepareand presenttopotentialclientson globaldatamanagement capabilities.
+ Reviewliteratureandresearchtechnologies/procedures forimprovingglobaldatamanagement practices.
+ Performother duties as assigned by management.
**Education / Qualifications**
+ University/collegedegree(lifescience,pharmacyorrelated subjectpreferred),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 process.
+ Understanding of globalclinicaldevelopmentbudgets andrelationshipto productivity targets.
+ Knowledge of effectiveclinicaldata management practices.
+ Knowledgeof timeandcost estimatedevelopmentandpricing strategies.
+ Thorough knowledgeofICHGuidelinesandGCPincludinginternational regulatoryrequirements for theconductof clinical development programs,especially asrelated to datahandlingand processing.
**Experience**
+ Minimumfive (5)yearsrelevant workexperiencein data managementwithapproximatelyone(1) yeartechnicalsupervisoryexperiencetoinclude datamanagement,clinicaloperations,andknowledgeof severaltherapeuticareas.
+ Demonstratedskillfortechnicalmanagement of staffexceeding5employees.
+ Financialmanagementof grossrevenuesinexcessof$250Kper year.
+ Excellentoraland writtencommunication andpresentationskills.
+ In depth knowledge of clinical trial process and data management, clinical operations,biometrics,qualitymanagement,andsystemsapplications tosupportoperations.
+ Workingknowledgeof therelationshipand regulatoryobligationof theCROindustry withpharmaceutical/biotechnological companies.
**Job Number** _2018-23790_
**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). Your confidentiality and privacy are important to us.
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Localización del Empleo: Portugal, Lisbon, otro
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Día de envío: 2018/10/12 / Viewed 19 times
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