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.

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'll also 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 Save ( student debtprogramandFreeU ( 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. Whether it's glucose 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 than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine ?nger sticks.

The Opportunity

Our location in Maple Grove MN currently has an on-site opportunity for an Associate Clinical Data Manager .? The Associate Clinical Data Manager?is?responsible?for?performing?data?management?tasks?within defined established processes throughout the life cycle of the study including startup,?conduct?and reporting phases.

What You' ll Work On

Works with Data Review Manager in the study start-up and planning, including contributing to the development of the Risk Assessment and Risk Mitigation Plan, Data Management Plan, Central Monitoring Plan?and Data Review Plan.?

Translates?Clinical Study requirements into technical requirements for eCRFs, edit?checks, study notifications and?customizations?in?the?study?database in 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?data/database 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?and/or?user?acceptance?testing?on?study?databases,?reports,studynotifications,?and?database?customizations.

• Utilize?existing?tools/reports,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 to data cleaning and data snapshot efforts for regulatory submissions and other business needs as requested?by?the?Clinical Study Team?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

• 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.

• 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?analytical/problem-solvingskills.??

• Mustbeabletoeffectivelymanagemultipleprojectsandtimelines.

• Requires?the?ability?to?sit?or?stand?while?working?ona?computer?for?a?long?period?of?time.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: (

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at , on Facebook at and on Twitter @AbbottNews.Connect with us at , on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.

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.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call View phone number on click.appcast.io or email View email address on click.appcast.io