Covance Clin Data Mgr I in Boston, Massachusetts

Job Overview

Data management leadershipon alarge I globalproject, ormultipleprojectswithresponsibilityfor thedevelopmentof theproject Data Management Plan; data managementsystems set-up; anddataaccession,data entry and data reviewspecifications andprocesses; andoversight ofdata managementactivitiesforthe deliveryof clinicaldataaccordingtoclientqualityand integrityspecifications,and project timelines and budgets.

Developandmaintainaclose liaisonwithproject client contacts, core teammembers, andProject Managers to drivethedata managementaspects ofproject delivery.

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 model and/ordatabasedesignandannotatetheCRF (eCFR) accordingto thesespecifications.

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

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.

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.

  • Knowledgeoftimeandcost 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.

  • Demonstratedskillfortechnicalmanagementof staffexceeding5employees.

  • Financialmanagementof grossrevenuesinexcessof$250Kper

  • Excellentoraland writtencommunication andpresentationskills.

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

  • Workingknowledgeof therelationshipand regulatoryobligationof theCROindustry withpharmaceutical I biotechnologica

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

  • Demonstratedmanagerialandinterpersonalskills

Job Number 2018-18448

Job Category Other

Position Type Full-Time

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