Associate Clinical Data Manager
Abbott
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JOB DESCRIPTION:
Working at AbbottĀ
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life.Ā YouāllĀ also have access to:Ā
Career development with an international company where you can grow the career you dream of.Ā
Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.Ā
An excellent retirement savings plan with high employer contributionĀ
Tuition reimbursement, theĀ Freedom 2 SaveĀ student debtĀ programĀ andĀ FreeUĀ education benefit - an affordable and convenient path to getting a bachelorās degree.Ā
A company recognized asĀ a great placeĀ to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.Ā Ā
A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.Ā Ā
For years, Abbottās medical device businesses have offered technologies that are faster, more effective, and less invasive. WhetherĀ itāsĀ glucose monitoring system, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more thanĀ 10,000 peopleĀ have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more thanĀ 500,000 peopleĀ with diabetes from routineĀ ļ¬ngerĀ sticks.Ā
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The OpportunityĀ -Ā CAN CHANGEĀ
Our locationĀ inĀ Ā MapleĀ GroveĀ MNĀ currently has an on-site opportunity for anĀ Associate Clinical Data Manager.āÆĀ TheĀ AssociateĀ Clinical Data ManagerāÆisāÆresponsibleāÆforāÆperformingāÆdataāÆmanagementāÆtasksāÆwithin defined established processes throughout the life cycle of the studyĀ including startup,āÆconductāÆand reporting phases.Ā
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WhatĀ YouāllĀ Work OnĀ -Ā CAN CHANGEĀ
WorksĀ withĀ Data Review ManagerĀ in theĀ studyĀ start-upĀ andĀ planning, including contributing to the development ofĀ theĀ RiskĀ AssessmentĀ andĀ Risk Mitigation Plan,Ā Data Management Plan,Ā Central MonitoringĀ PlanāÆand Data Review Plan.āÆĀ
TranslatesāÆClinicalĀ StudyĀ requirementsĀ intoĀ technicalĀ requirementsĀ forĀ eCRFs,Ā editāÆchecks,Ā studyĀ notificationsĀ andāÆcustomizationsāÆināÆtheāÆstudyāÆdatabaseĀ in close collaboration with otherāÆmemberāÆof the data review team.āÆĀ
Able to developāÆCRF with cross functional support, incorporatingĀ appropriateĀ feedbackĀ andĀ finalizingĀ theĀ CRF.āÆĀ
Able to developĀ specifications forĀ dataāÆĀ listingsĀ forĀ continuous dataĀ review,Ā andĀ communicate withĀ data analyticsĀ team membersĀ through their development and release.āÆĀ
Able to work with external non-CRF data,āÆincluding developingāÆcreating Data Transfer Specifications,Ā verification ofāÆexternal data structure for import into theĀ data model.āÆĀ
Able to develop edit check specifications toĀ reviewĀ for illogical,āÆincompleteāÆand inconsistent data includingĀ testing and troubleshooting ofāÆeditsāÆchecks.āÆĀ
Identifies,āÆanalyzes,āÆproposesāÆsolutions,āÆandāÆeffectivelyāÆresolvesāÆcomplexāÆdata/database structureĀ issuesĀ byĀ exercisingĀ appropriateĀ judgmentĀ andĀ collaboratingĀ withĀ theĀ clinicalĀ projectĀ teamĀ membersĀ andĀ otherĀ sharedĀ serviceāÆfunctions.Ā
ContributesāÆtoāÆtheāÆdevelopmentāÆandāÆmaintenanceāÆofĀ ClinicalĀ DatabaseĀ systems,Ā includingĀ EDC,Ā EditĀ Checks,Ā Reporting,Ā StudyāÆNotifications,āÆetc.āÆthroughāÆtheāÆfollowing:āÆĀ
PartnerāÆcloselyāÆwithāÆData ReviewāÆManagement,Ā StudyĀ DatabaseĀ Manager, andĀ DataĀ Analytics andĀ SystemsĀ and other Data Review team members.āÆāÆĀ
PerformāÆandāÆdocumentāÆfunctionalāÆand/orāÆuserāÆacceptanceāÆtestingāÆonāÆstudyāÆdatabases,āÆreports,Ā studyĀ notifications,āÆandāÆdatabaseāÆcustomizations.Ā
UtilizeāÆexistingāÆtools/reports,SQL,Ā andĀ databaseĀ UIĀ toĀ identifyĀ dataĀ issuesĀ andĀ driveĀ resolutionsĀ withĀ theāÆClinicalĀ StudyĀ TeamĀ inĀ aĀ timelyĀ manner.āÆĀ
AttendāÆClinicalĀ StudyĀ TeamĀ meetings.Ā
Contribute technicalāÆexpertiseāÆto cross functional teams through CRF changes and the impact on databases and propose implementation strategies.āÆāÆĀ
AssistsāÆināÆFDAāÆandāÆQualityĀ SystemāÆauditsāÆthatāÆinvolveāÆClinicalĀ DatabaseāÆandāÆData ManagementāÆĀ
FollowsāÆdataāÆmanagementāÆstandardsāÆandāÆbestāÆpracticesāÆandāÆassuresāÆStandardāÆprocessesāÆareāÆfollowedāÆforāÆData ManagementāÆactivities.āÆĀ
Contribute toĀ dataĀ cleaningĀ andĀ dataĀ snapshotĀ effortsĀ forĀ regulatoryĀ submissionsĀ andĀ otherĀ businessĀ needsĀ asĀ requestedāÆbyāÆtheāÆClinicalĀ StudyĀ TeamāÆthroughāÆtheāÆfollowing:āÆĀ
Generate databaseāÆsnapshotāÆand prepare datasets forĀ Biometrics.āÆĀ
Contribute toāÆdataāÆreviewāÆmeetingsāÆwithāÆtheāÆClinicalĀ StudyĀ TeamĀ andĀ BiometricsĀ toĀ identifyĀ dataĀ cleaningĀ issuesāÆandāÆstrategizeāÆcleaningāÆefforts.Ā
MonitorĀ overallĀ dataĀ managementĀ tasksĀ toĀ ensureĀ thatĀ timelinesĀ areĀ metĀ andĀ thatĀ anyĀ issuesĀ areĀ proactivelyĀ identifiedĀ andĀ resolved.āÆĀ
PerformāÆotherāÆdutiesāÆasāÆassigned.āÆĀ
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Required QualificationsĀ āĀ CANāTĀ CHANGEĀ
Bachelorās degree in a related fieldĀ OR an equivalentĀ combinationĀ of education and work experience.Ā
MinimumĀ 3Ā yearsāĀ in clinical, medical or research setting.Ā
Education and work experience in computer science, lifeĀ sciencesĀ or technicalĀ field.Ā
Knowledge of data collection best practices for clinical trials.Ā
Knowledge of global clinical operations.Ā
Intermediate therapy specific knowledge of anatomy, physiology, pathophysiology,Ā therapyĀ and device.Ā
Intermediate medical knowledge related to common medical histories, medical terminology, diagnostics (imaging, laboratory), and medications (class, dose, route).Ā
Certified Clinical Data Manager (CCDM) or equivalent.Ā
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PreferredāÆQualificationsĀ āĀ CAN CHANGEĀ
BachelorāsĀ degree inĀ business administration, dataĀ science,Ā statisticsĀ or life sciences.Ā
3Ā yearsā experience inĀ clinical operations or healthcare relatedĀ field.Ā
KnowledgeāÆofāÆdataāÆmanagementāÆpracticesāÆfromāÆCRFāÆdesignāÆtoāÆdatabaseāÆdevelopmentāÆandāÆstudyāÆclosure.āÆāÆĀ
ExperienceāÆwithāÆusingāÆElectronicĀ Data CaptureĀ (EDC)āÆdatabasesĀ andĀ advancedĀ skill levelĀ working inĀ Excel.Ā
Knowledge of documentation practices in-line withāÆGoodĀ ClinicalĀ DataĀ ManagementĀ Practices,Ā andĀ otherĀ FDAĀ regulationsāÆandāÆguidelinesāÆisāÆrequired.āÆāÆĀ
AbilityāÆtoāÆleverageāÆand/orāÆengageāÆothersāÆtoāÆaccomplishāÆprojects.āÆĀ
SolidāÆoralāÆandāÆwrittenāÆcommunicationāÆskillsāÆandāÆanalytical/problem-solvingĀ skills.āÆāÆĀ
MustĀ beĀ ableĀ toĀ effectivelyĀ manageĀ multipleĀ projectsĀ andĀ timelines.Ā
RequiresāÆtheāÆabilityāÆtoāÆsitāÆorāÆstandāÆwhileāÆworkingāÆonĀ aāÆcomputerāÆforāÆaāÆlongāÆperiodāÆofāÆtime.Ā
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The base pay for this position is
$61,300.00 ā $122,700.00In specific locations, the pay range may vary from the range posted.
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JOB FAMILY:
Clinical Affairs / Statistics
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DIVISION:
MD Medical Devices
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LOCATION:
United States > Maple Grove : 6820 Wedgwood Road N.
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ADDITIONAL LOCATIONS:
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WORK SHIFT:
Standard
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TRAVEL:
Yes, 5 % of the Time
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MEDICAL SURVEILLANCE:
No
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SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
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Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.Ā Ā Ā
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdfĀ Ā Ā
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdfThe average job posting receives 250 applications.
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