Associate Clinical Data Manager

Abbott

Maple Grove (MN)

On-site

USD 61,000 - 123,000

Full time

14 days+

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Benefits offered by this job

Free medical coverage in HIP PPO plan

Tuition reimbursement and educationBEN

Retirement savings plan with employer

Global career development

Job summary

Abbott in Maple Grove, MN is hiring an Associate Clinical Data Manager. You will perform data management tasks across the study life cycle, from startup through reporting, ensuring data integrity and regulatory compliance.

The role requires a clinical data management background, knowledge of CRFs, edit checks, and data transfer specifications, plus collaboration with cross-functional teams. Abbott offers strong benefits and opportunities within a global health leader.

Qualifications

Bachelor’s degree in a related field or equivalent experience.
Minimum 3 years in a clinical, medical or research setting.
Education and work experience in computer science, life sciences or technical field.
Knowledge of data collection best practices for clinical trials.
Knowledge of global clinical operations.
Intermediate therapy-specific knowledge of anatomy, physiology, pathophysiology, therapy and device.
Intermediate medical knowledge related to common medical histories, medical terminology, diagnostics, and medications.
Certified Clinical Data Manager (CCDM) or equivalent.

Responsibilities

Works with Data Review Manager in study start-up and planning, contributing to risk assessments and plans.
Translates clinical study requirements into CRFs, edit checks, notifications in the study database with the data review team.
Develops CRFs with cross-functional support and finalizes the CRF.
Develops specifications for data listings and communicates with analytics teams.
Works with external non-CRF data and data transfer specifications.
Develops edit check specifications to review data quality.
Identifies and resolves complex data/database issues with judgment and collaboration.
Contributes to development/maintenance of Clinical Databases systems (EDC, edit checks, reporting).
Performs functional/user acceptance testing on study databases, reports, notifications, and customizations.
Uses SQL and tools to identify data issues and drive resolutions.

Skills

Attention to detail

Analytical thinking

Strong communication skills

Project management

Education

Bachelor's degree in a related field

CCD M certification or equivalent

Bachelor's degree in data-related field (preferred)

Tools

EDC databases

SQL

Excel

Job 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, 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