Associate Clinical Data Manager

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, the Freedom 2 Save student debtprogramand FreeU education 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 routine fingersticks. The Opportunity- Our locationinMapleGroveMNcurrently has an on-site opportunity for an Associate Clinical Data Manager.TheAssociateClinical Data Managerisresponsibleforperformingdatamanagementtaskswithin defined established processes throughout the life cycle of the studyincluding startup, conductand reporting phases. WhatYou’ll Work On- 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 othermemberof the data review team. Able to developCRF with cross functional support, incorporatingappropriatefeedbackandfinalizingtheCRF. Able to developspecifications fordatalistingsforcontinuous datareview,andcommunicate withdata analyticsteam membersthrough their development and release. Able to work with external non-CRF data,including developingcreating Data Transfer Specifications,verification ofexternal data structure for import into thedata model. Able to develop edit check specifications toreviewfor illogical,incompleteand inconsistent data includingtesting and troubleshooting ofeditschecks. Identifies,analyzes,proposessolutions,andeffectivelyresolvescomplexdata/database structureissuesbyexercisingappropriatejudgmentandcollaboratingwiththeclinicalprojectteammembersandothersharedservicefunctions. ContributestothedevelopmentandmaintenanceofClinicalDatabasesystems,includingEDC,EditChecks,Reporting,StudyNotifications,etc.throughthefollowing: PartnercloselywithData ReviewManagement,StudyDatabaseManager, andDataAnalytics andSystemsand other Data Review team members. Performanddocumentfunctionaland/oruseracceptancetestingonstudydatabases,reports,studynotifications,anddatabasecustomizations. Utilizeexistingtools/reports,SQL,anddatabaseUItoidentifydataissuesanddriveresolutionswiththeClinicalStudyTeaminatimelymanner. AttendClinicalStudyTeammeetings. Contribute technicalexpertiseto cross functional teams through CRF changes and the impact on databases and propose implementation strategies. AssistsinFDAandQualitySystemauditsthatinvolveClinicalDatabaseandData Management FollowsdatamanagementstandardsandbestpracticesandassuresStandardprocessesarefollowedforData Managementactivities. Contribute todatacleaninganddatasnapshoteffortsforregulatorysubmissionsandotherbusinessneedsasrequestedbytheClinicalStudyTeamthroughthefollowing: Generate databasesnapshotand prepare datasets forBiometrics. Contribute todatareviewmeetingswiththeClinicalStudyTeamandBiometricstoidentifydatacleaningissuesandstrategizecleaningefforts. Monitoroveralldatamanagementtaskstoensurethattimelinesaremetandthatanyissuesareproactivelyidentifiedandresolved. Performotherdutiesasassigned. Required Qualifications– 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– 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 withGoodClinicalDataManagementPractices,andotherFDAregulationsandguidelinesisrequired. Abilitytoleverageand/orengageotherstoaccomplishprojects. Solidoralandwrittencommunicationskillsandanalytical/problem-solvingskills. Mustbeabletoeffectivelymanagemultipleprojectsandtimelines. Requirestheabilitytositorstandwhileworkingonacomputerforalongperiodoftime. 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: EEO is the Law link - Espanol: #J-18808-Ljbffr Abbott