
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
Our location inMapleGroveMNcurrently has an on-site opportunity for anAssociate Clinical Data Manager As the customer-face oftheData Reviewteamand its primary liaison with theClinicalprojectteam, theAssociateClinical Data Manager’s in-depthclinical operations andtherapy-specific knowledge ensures alignment to customerneeds, andinforms review and analysis of study data
WhatYou’llWork On
Leads andfacilitatesan ongoing evaluation of risk involving in-depth review of protocol and plan documentation, discussion and validationrisk-related findings with cross-functional workgroup, and the development of systems and process-based controls to mitigateidentifiedrisks. These responsibilities include:
Leading cross-functional teams during protocol development toidentifyand document those data which are critical to the reliability of study results and the protection of human subjects
Managing the development and revision of the critical processes (e.g.CRF design, Edit Checks, data listings, and clinical database setup) by which those data will be captured and managed throughout the clinical investigation
Identifyingand evaluating residual risks to critical study data and supervising the development ofadditionalmitigations including focused data cleaning and quality activity, targeted site instruction, and study-specific Central and Site Monitoring plans
Leads the Clinical Project Team through the development of Case Report Forms and partners with the Study Database Manager through study database development and release, includingidentifying,programmingand testing edit checks.
Conducts complex review and analysis of subject data as it accumulates, resolving discrepant or aberrant data points via individual queries to study sites, as well as the identification of systemic and/or significant data quality issues requiring escalation; manages escalation efforts and drives them to resolution in partnership with Project Management, Site Management, Clinical Science, Biometrics, Safety, and organizational leaders.
Manages progress towards data cleaning and data freeze/lock targets for regulatory submission, and other business needs asidentifiedby the Clinical Project Team.
Manages, with dedicated support of the Clinical Data Coordinator, the study-wide issuance and resolution of discrepancies over the study lifecycle.
Overseesthe maintenance of data review standards and best practices, ensuring adherence informed by therapy-specificexpertise
Leads proactive partnership, on both an ad hoc and period/prescribed basic, with field and study team personnel, presenting findings and issues uncovered during data review, devising and documenting appropriate resolution and escalation strategies, and managing the overall health of data quality and study conduct through milestones and deliverables over the lifecycle of the study.
Required Qualifications
Bachelor’s degree in a related fieldOR an equivalent combination of education and work experience.
Minimum 4years’related workexperiencewith a solid understanding of specified functional area
Broad knowledge and application of business concepts,proceduresand practices
Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations
Learnsto use professional concepts and company policies and procedures to solve routine problems.
Works on problemsoflimited scopeIndependent decision makingrequired
Preferred Qualifications
Bachelor’sdegree inbusiness administration, datascience,statisticsor life sciences.
3-5 years’ experience inclinical operations or healthcare related field
Strong verbal and written communications withabilityto effectively communicate at multiple levels in the organization.
Excellent analytical skills and ability to manage complex tasks and manage time effectively
Prior data management experiencerequired
The base pay for this position is
$78,000.00 – $156,000.00
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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