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.
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, the Freedom 2 Savestudent debtprogramand FreeUeducation 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 Manager is responsible for performing data management tasks 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 MonitoringPlan and Data Review Plan.
Translates ClinicalStudyrequirementsintotechnicalrequirementsforeCRFs,edit checks,studynotificationsand customizations in the study databasein 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, proposes solutions, and effectively resolves complex datadatabase structureissuesbyexercisingappropriatejudgmentandcollaboratingwiththeclinicalprojectteammembersandothersharedservice functions
Contributes to the development and maintenance ofClinicalDatabasesystems,includingEDC,EditChecks,Reporting,Study Notifications, etc through the following
Partner closely with Data Review Management,StudyDatabaseManager, andDataAnalytics andSystemsand other Data Review team members.
Perform and document functional andor user acceptance testing on study databases, reports,studynotifications, and database customizations
Utilize existing toolsreports,SQL,anddatabaseUItoidentifydataissuesanddriveresolutionswiththe ClinicalStudyTeaminatimelymanner
Attend ClinicalStudyTeammeetings
Contribute technical expertise to cross functional teams through CRF changes and the impact on databases and propose implementation strategies.
Assists in FDA and QualitySystem audits that involve ClinicalDatabase and Data Management
Follows data management standards and best practices and assures Standard processes are followed for Data Management activities
Contribute todatacleaninganddatasnapshoteffortsforregulatorysubmissionsandotherbusinessneedsasrequested by the ClinicalStudyTeam through the following
Generate database snapshot and prepare datasets forBiometrics.
Contribute to data review meetings with the ClinicalStudyTeamandBiometricstoidentifydatacleaningissues and strategize cleaning efforts
Monitoroveralldatamanagementtaskstoensurethattimelinesaremetandthatanyissuesareproactivelyidentifiedandresolved
Perform other duties as assigned
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.
Preferred Qualifications–CAN CHANGE
Bachelor’sdegree inbusiness administration, datascience,statisticsor life sciences.
3years’ experience inclinical operations or healthcare relatedfield
Knowledge of data management practices from CRF design to database development and study closure
Experience with using ElectronicData Capture(EDC) databasesandadvancedskill levelworking inExcel
Knowledge of documentation practices in-line with GoodClinicalDataManagementPractices,andotherFDAregulations and guidelines is required
Ability to leverage and/or engage others to accomplish projects.
Solid oral and written communication skills and analyticalproblem-solvingskills
Mustbeabletoeffectivelymanagemultipleprojectsandtimelines
Requires the ability to sit or stand while working ona computer for a long period of time
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.
Clinical Affairs / Statistics
MD Medical Devices
United States > Maple Grove : 6820 Wedgwood Road N.
Standard
Yes, 5 % of the Time
No
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
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, nutritional and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and www.facebook.com/AbbottCareers, on Instagram @AbbottGlobal, and on X @AbbottNews.
We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.
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