Covance Clin Data Mgr I in NC, United States

Job Overview

Lead Clinical Data Manager

Permanent, Salaried

Remote from anywhere in the U.S. or Canada

Responsibilities

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 and

+Serve asthe projectand clientliaisonincludingmanagement andprovisionofprojectspecificdata managementstatus, cycle time, andproductivity metrics.

+Coordinate andpaiticipate i n thedevelopment oftheclinicaldata modeland/ordatabasedesignandannotatetheCRF (eCFR) accordingto thesespecifications.

+Reviewdata acquisition conventions anddata reviewguidelines I diagnosticspecifications consistent with the clinicaldata model,[statistical] analysis plans, and CRF (eCRF) completion

I monitoringconventions.

+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 specialtyteammembers (clinical,programming, statistics, CDMtechnicalsuppo1t,drug safety,etc.) tosuppo1ttheset-up,maintenance, andclosureofthedata managementaspectsoftheprojecttoensure consistent, cohesive data handlingand quality.

  • Advanced planning and risk management for projects(issueescalation, resource management).

+Overseethe technicalpe1formance ofthe data reviewprojectstaff on achieving client satisfaction through delivery ofquality data,on-time and on-budget.

  • Assist with goal creation and performancereviewassessment fordatareview project staff.

+Maintaintechnicaldatamanagementcompetencies via pa1ticipationininternal and external training seminars.

+Ensureproject staff aretrainedand adheretoproject-specific, global, standardizeddatamanagement processes.

+Identifyareas forprocessand efficiencyimprovementandimplementsolutions on assigned projects.

+Support achievement of project revenue and operatingmarginfor data management activitiestoagreedtargets.

Experience

University/collegedegree(lifescience,pharmacyorrelatedsubjectpreferred),or certification

  • in a relatedalliedhealthprofession from an appropriately accredited institution (e.g., nursingce11ification,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.

  • Knowledgeoftimeandcost estimatedevelopmentandpricing strategies.

  • Thorough knowledgeofTCHGuidelinesandGCPincludinginternational regulatoryrequirements for theconductof clinical development programs,especially asrelated to datahandlingandprocessing.

Education/Qualifications

Minimumfive (5)yearsrelevant workexperiencein data managementwithapproximatelyone( 1 ) yeartechnicalsupervisoryexperiencetoinclude datamanagement,clinicaloperations,andknowledgeof severaltherapeuticareas.

  • Demonstratedskillfortechnicalmanagementof staffexceeding5employees.

  • Financialmanagementof grossrevenuesinexcessof$250Kper

  • Excellentoraland writtencommunication andpresentationskills.

  • In depthknowledgeofclinicaltrialprocess anddatamanagement,clinicaloperations,biometrics,qualitymanagement,andsystemsapplications tosupportoperation

  • Workingknowledgeof therelationshipand regulatoryobligationof theCROindustry withpharmaceutical I biotechnologica

  • Ability to lead byexampleteams on project strategies and achievement of depa11mentgoals,objectives,andinitiatives andtoencourage team members to seeksolutions.

  • Demonstratedmanagerialandinterpersonalskills

Education/Qualifications

Minimumfive (5)yearsrelevant workexperiencein data managementwithapproximatelyone( 1 ) yeartechnicalsupervisoryexperiencetoinclude datamanagement,clinicaloperations,andknowledgeof severaltherapeuticareas.

  • Demonstratedskillfortechnicalmanagementof staffexceeding5employees.

  • Financialmanagementof grossrevenuesinexcessof$250Kper

  • Excellentoraland writtencommunication andpresentationskills.

  • In depthknowledgeofclinicaltrialprocess anddatamanagement,clinicaloperations,biometrics,qualitymanagement,andsystemsapplications tosupportoperation

  • Workingknowledgeof therelationshipand regulatoryobligationof theCROindustry withpharmaceutical I biotechnological

  • Ability to lead byexampleteams on project strategies and achievement of depa11mentgoals,objectives,andinitiatives andtoencourage team members to seeksolutions.

  • Demonstratedmanagerialandinterpersonalskills

    Experience

  • University/collegedegree(lifescience,pharmacyorrelatedsubjectpreferred),or certification

  • in a relatedalliedhealthprofession from an appropriately accredited institution (e.g., nursingce11ification,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.

  • Knowledgeoftimeandcost estimatedevelopmentandpricing strategies.

  • Thorough knowledgeofTCHGuidelinesandGCPincludinginternational regulatoryrequirements for theconductof clinical development programs,especially asrelated to datahandlingandprocessing.

Job Number 2018-20901

Job Category Other

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.