Covance Clin Data Mgr I in Maidenhead, United Kingdom

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 clientrelationshipsandreceiveclientsatisfactionsurveysandimplementappropriate 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.