Associate Clinical Data Manager

Abbott

United States - Minnesota - Maple GroveFull-timePosted 13 days ago

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Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.

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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 You’llĀ 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 bachelor’s 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, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive. WhetherĀ it’sĀ 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 routine fingerĀ 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.  TheĀ AssociateĀ Clinical Data Manager is responsible for performing data management tasks within defined established processes throughout the life cycle of the studyĀ including startup, conduct and reporting phases.Ā 

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WhatĀ You’llĀ 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 Plan and Data Review Plan.  

Translates ClinicalĀ StudyĀ requirementsĀ intoĀ technicalĀ requirementsĀ forĀ eCRFs,Ā edit checks,Ā studyĀ notificationsĀ and customizations in the study databaseĀ in close collaboration with other member of the data review team.  

  • Able to develop CRF with cross functional support, incorporatingĀ appropriateĀ feedbackĀ andĀ finalizingĀ theĀ CRF.  

  • Able to developĀ specifications forĀ data  listingsĀ forĀ continuous dataĀ review,Ā andĀ communicate withĀ data analyticsĀ team membersĀ through their development and release.  

  • Able to work with external non-CRF data, including developing creating Data Transfer Specifications,Ā verification of external data structure for import into theĀ data model.  

  • Able to develop edit check specifications toĀ reviewĀ for illogical, incomplete and inconsistent data includingĀ testing and troubleshooting of edits checks.  

  • Identifies, analyzes, proposes solutions, and effectively resolves complex data/database structureĀ issuesĀ byĀ exercisingĀ appropriateĀ judgmentĀ andĀ collaboratingĀ withĀ theĀ clinicalĀ projectĀ teamĀ membersĀ andĀ otherĀ sharedĀ service functions.Ā 

  • Contributes to the development and maintenance ofĀ ClinicalĀ DatabaseĀ systems,Ā includingĀ EDC,Ā EditĀ Checks,Ā Reporting,Ā Study Notifications, etc. through the following:  

  • Partner closely with Data Review Management,Ā StudyĀ DatabaseĀ Manager, andĀ DataĀ Analytics andĀ SystemsĀ and other Data Review team members.   

  • Perform and document functional and/or user acceptance testing on study databases, reports,Ā studyĀ notifications, and database customizations.Ā 

  • Utilize existing tools/reports,SQL,Ā andĀ databaseĀ UIĀ toĀ identifyĀ dataĀ issuesĀ andĀ driveĀ resolutionsĀ withĀ the ClinicalĀ StudyĀ TeamĀ inĀ aĀ timelyĀ manner.  

  • Attend ClinicalĀ StudyĀ TeamĀ meetings.Ā 

  • Contribute technical expertise to cross functional teams through CRF changes and the impact on databases and propose implementation strategies.   

  • Assists in FDA and QualityĀ System audits that involve ClinicalĀ Database and Data Management  

Follows data management standards and best practices and assures Standard processes are followed for Data Management activities.  

Contribute toĀ dataĀ cleaningĀ andĀ dataĀ snapshotĀ effortsĀ forĀ regulatoryĀ submissionsĀ andĀ otherĀ businessĀ needsĀ asĀ requested by the ClinicalĀ StudyĀ Team through the following:  

  • Generate database snapshot and prepare datasets forĀ Biometrics.  

  • Contribute to data review meetings with the ClinicalĀ StudyĀ TeamĀ andĀ BiometricsĀ toĀ identifyĀ dataĀ cleaningĀ issues and strategize cleaning efforts.Ā 

  • MonitorĀ overallĀ dataĀ managementĀ tasksĀ toĀ ensureĀ thatĀ timelinesĀ areĀ metĀ andĀ thatĀ anyĀ issuesĀ areĀ proactivelyĀ identifiedĀ andĀ resolved.  

Perform other duties as assigned.  

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Required Qualifications – CAN’TĀ CHANGEĀ 

  • Bachelor’s degree in a related fieldĀ OR an equivalentĀ combinationĀ of education and work experience.Ā 

  • MinimumĀ 3Ā years’ 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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Preferred Qualifications – CAN CHANGEĀ 

  • Bachelor’sĀ degree inĀ business administration, dataĀ science,Ā statisticsĀ or life sciences.Ā 

  • 3Ā years’ experience inĀ clinical operations or healthcare relatedĀ field.Ā 

  • Knowledge of data management practices from CRF design to database development and study closure.   

  • Experience with using ElectronicĀ Data CaptureĀ (EDC) databasesĀ andĀ advancedĀ skill levelĀ working inĀ Excel.Ā 

  • Knowledge of documentation practices in-line with GoodĀ ClinicalĀ DataĀ ManagementĀ Practices,Ā andĀ otherĀ FDAĀ regulations and guidelines is required.   

  • Ability to leverage and/or engage others to accomplish projects.  

  • Solid oral and written communication skills and analytical/problem-solvingĀ skills.   

  • MustĀ beĀ ableĀ toĀ effectivelyĀ manageĀ multipleĀ projectsĀ andĀ timelines.Ā 

  • Requires the ability to sit or stand while working onĀ a computer for a long period of time.Ā 

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The base pay for this position is

$61,300.00 – $122,700.00

In 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.

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EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

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EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

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