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Associate Clinical Data Manager

United States - Minnesota - Maple GroveOn-siteFull-time

AI Summary

Associate Clinical Data Manager responsible for data management tasks across clinical study lifecycle phases, including CRF development, edit checks, database customization, data cleaning, and regulatory audit support.

About this role

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.

JOB DESCRIPTION:

Working at Abbott

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.You’llalso have access to:

  • Career development with an international company where you can grow the career you dream of.

  • Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.

  • An excellent retirement savings plan with high employer contribution

  • Tuition reimbursement, theFreedom 2 Savestudent debtprogramandFreeUeducation benefit - an affordable and convenient path to getting a bachelor’s degree.

  • A company recognized asa great placeto work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.

  • 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.

For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive. Whetherit’sglucose 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 than10,000 peoplehave healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than500,000 peoplewith diabetes from routinefingersticks.

The Opportunity-CAN CHANGE

Our locationin MapleGroveMNcurrently has an on-site opportunity for anAssociate Clinical Data Manager. TheAssociateClinical Data Managerisresponsibleforperformingdatamanagementtasks within defined established processes throughout the life cycle of the studyincluding startup, conduct and reporting phases.

WhatYou’llWork On-CAN CHANGE

WorkswithData Review Managerin thestudystart-upandplanning, including contributing to the development oftheRiskAssessmentandRisk Mitigation Plan,Data Management Plan,Central MonitoringPlanand Data Review Plan.

TranslatesClinicalStudyrequirementsintotechnicalrequirementsforeCRFs,editchecks,studynotificationsandcustomizationsinthestudydatabasein close collaboration with other member of the data review team. 

  • Able to develop CRF with cross functional support, incorporatingappropriatefeedbackandfinalizingtheCRF. 

  • Able to developspecifications fordata listingsforcontinuous datareview,andcommunicate withdata analyticsteam membersthrough their development and release. 

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

  • Able to develop edit check specifications toreviewfor illogical, incomplete and inconsistent data includingtesting and troubleshooting of edits checks. 

  • Identifies, analyzes, proposessolutions, andeffectivelyresolvescomplexdata/database structureissuesbyexercisingappropriatejudgmentandcollaboratingwiththeclinicalprojectteammembersandothersharedservicefunctions.

  • ContributestothedevelopmentandmaintenanceofClinicalDatabasesystems,includingEDC,EditChecks,Reporting,Study Notifications, etc. throughthefollowing:

  • Partner closelywith Data Review Management,StudyDatabaseManager, andDataAnalytics andSystemsand other Data Review team members.

  • Performanddocumentfunctionaland/oruseracceptancetestingonstudydatabases, reports,studynotifications, anddatabasecustomizations.

  • Utilizeexistingtools/reports,SQL,anddatabaseUItoidentifydataissuesanddriveresolutionswiththeClinicalStudyTeaminatimelymanner.

  • AttendClinicalStudyTeammeetings.

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

  • Assistsin FDA and QualitySystemauditsthatinvolveClinicalDatabase and Data Management

Followsdatamanagementstandardsandbestpracticesandassures Standard processesarefollowedfor Data Management activities. 

Contribute todatacleaninganddatasnapshoteffortsforregulatorysubmissionsandotherbusinessneedsasrequestedbytheClinicalStudyTeam throughthefollowing:

  • Generate database snapshot and prepare datasets forBiometrics. 

  • Contribute todatareviewmeetingswiththeClinicalStudyTeamandBiometricstoidentifydatacleaningissuesandstrategizecleaningefforts.

  • Monitoroveralldatamanagementtaskstoensurethattimelinesaremetandthatanyissuesareproactivelyidentifiedandresolved.

Performotherdutiesasassigned.

Required Qualifications–CAN’TCHANGE

  • Bachelor’s degree in a related fieldOR an equivalentcombinationof education and work experience.

  • Minimum3years’in clinical, medical or research setting.

  • Education and work experience in computer science, lifesciencesor technicalfield.

  • Knowledge of data collection best practices for clinical trials.

  • Knowledge of global clinical operations.

  • Intermediate therapy specific knowledge of anatomy, physiology, pathophysiology,therapyand device.

  • Intermediate medical knowledge related to common medical histories, medical terminology, diagnostics (imaging, laboratory), and medications (class, dose, route).

  • Certified Clinical Data Manager (CCDM) or equivalent.

PreferredQualifications–CAN CHANGE

  • Bachelor’sdegree inbusiness administration, datascience,statisticsor life sciences.

  • 3years’ experience inclinical operations or healthcare relatedfield.

  • KnowledgeofdatamanagementpracticesfromCRFdesigntodatabasedevelopmentandstudyclosure.  

  • ExperiencewithusingElectronicData Capture(EDC)databasesandadvancedskill levelworking inExcel.

  • Knowledge of documentation practices in-line with GoodClinicalDataManagementPractices,andotherFDAregulationsandguidelinesisrequired.  

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

  • Solidoralandwrittencommunicationskillsandanalytical/problem-solvingskills.

  • Mustbeabletoeffectivelymanagemultipleprojectsandtimelines.

  • Requirestheabilitytositorstandwhileworkingona computerfor a longperiodoftime.

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.

JOB FAMILY:

Clinical Affairs / Statistics

DIVISION:

MD Medical Devices

LOCATION:

United States > Maple Grove : 6820 Wedgwood Road N.

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Yes, 5 % of the Time

MEDICAL SURVEILLANCE:

No

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)Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Skills

Biometrics DatasetsCentral Monitoring PlanClinical Database SystemsCRF DesignDatabase CustomizationsDatabase UIData ListingsData Management PlanData SnapshotData Transfer SpecificationsEdit ChecksElectronic Data Capture (EDC)FDA RegulationsFunctional TestingGood Clinical Data Management PracticesRisk Assessment And Mitigation PlanSQLStudy NotificationsUser Acceptance Testing

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