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Associate Clinical Data Manager

Abbott

  • Maple Grove, Minnesota
  • 6 days ago
  • $61,300–$122,700 Per Year
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Skills

  • Analysis Skillsunmatched
  • Anatomyunmatched
  • Best Practicesunmatched
  • Biologyunmatched
  • Career Developmentunmatched
  • Case Report Form (CRF)unmatched
  • Clinical Data Collectionunmatched
  • Clinical Data Managementunmatched
  • Clinical Practices/Protocolsunmatched
  • Computer Scienceunmatched
  • Computer Skillsunmatched
  • Cross-Functionalunmatched
  • Data Managementunmatched
  • Data Setsunmatched
  • Data Structuresunmatched
  • Diabetesunmatched
  • Diseaseunmatched
  • Diversityunmatched
  • Health Planunmatched
  • Healthcareunmatched
  • Identify Issuesunmatched
  • International Healthunmatched
  • Keyboardsunmatched
  • Medical Diagnosisunmatched
  • Medical Equipmentunmatched
  • Medical Productsunmatched
  • Medical Researchunmatched
  • Medical Terminologyunmatched
  • Medicationsunmatched
  • Medicineunmatched
  • Physiologyunmatched
  • Preferred Provider Organization (PPO)unmatched
  • Process Developmentunmatched
  • Retirement Planunmatched
  • Startupunmatched
  • Surveillanceunmatched
  • Tuition Reimbursementunmatched

Description

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 routinengersticks.

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,andotherFDAregulationsandguidelinesis.  

  • 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

Numbers & Facts

LocationMaple Grove, Minnesota
IndustryHealthcare Services
Salary$61,300–$122,700 Per Year
Company Size10,000 employees or more
Year Founded1910
Websitehttp://www.abbott.com/

About Company

At Abbott, we are enthusiastic, energetic and committed to doing great work every day. Our employees are passionate about helping to translate science into lasting contributions to health care and the health of people worldwide. At the heart of our organization is our "Promise for Life"—a statement that embodies our company's commitment to employees, shareholders, local communities and the people who depend on our company and products to live healthier lives.

Vital to our promise is the speed in which we act, respond and deliver. As Abbott employees, we are ready to meet change and challenges head-on. As a result, we are a company that adapts quickly, and through our passion for innovation we are able to continually create a pipeline of products that help improve the length and quality of life around the world.

We are proud of our rich, more than 120-year history. We continue to be driven to advance leading-edge science and technologies, support diversity, focus on exceptional performance and earn the trust of those we serve.

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