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’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, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.

A company recognized as a great place to 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 finger sticks.

The Opportunity - CAN CHANGE Our location in Maple Grove MN currently has an on-site opportunity for a n Associate Clinical Data Manager .  Th e As sociate Cl inical D ata M anager   is   responsible   for   performing   data   management   tasks  within defined established processes throughout the life cycle of the study i ncluding startup,  conduct  and reporting phases.

What You’ ll Work On - CAN CHANGE Work s with Data Review Manager in the stu dy 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. Translate s   Clinical Study requirements into technical requirements for eCRFs , edit   checks , study notifications and   customizations   in   the   study   databas e in close collaboration with other  member  of the data review team. Able to develop CRF with cross functional support, incorporating appropriate feedback and finalizing the CRF.

Able to develop speci fications for data  listings for continuous data review, and communicate with data analytics team members through 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 the data model .

Able to develop edit check specifications to review for illogical,  incomplete  and inconsistent data including testing and troubleshooting of  edits  checks.

Identif ies ,  analyze s ,  propose s   solutions ,  and   effectively   resolve s   complex   data /database structure issues by exercising appropriate judgment and collaborating with the clinical project team members and other shared service   functions .

Contributes   to   the   development   and   maintenance   of Clinical Database systems , including EDC, Edit Checks , Reporting, Study  Notifications ,  etc .  through   the   following :

Partner  closely   with  D ata Review  Management , S tudy Database Manager , and Data Analytics and Systems and other Data Review team member s.

Perform   and   document   functional   and / or   user   acceptance   testing   on   study   databases ,  reports , stu d y notifications ,  and   database   customizations .

Utilize   existing   tools / reports,SQL , and database UI to identify data issues and drive resolutions with the   Clinical Study Team in a timely manner .

Attend   Clinical Study Team meetings .

Contribute technical  expertise  to cross functional teams through CRF changes and the impact on databases and propose implementation strategies.

Assists   in  FDA  and  Quality System   audits   that   involve   Clinical Database  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 for B iometrics.

Contribute to   data   review   meetings   with   the   Clinical Study Team and Biometrics to identify data cleaning issues   and   strategize   cleaning   efforts .

M onitor overall data management tasks to ensure that timelines are met and that any issues are proactively identified and resolved .

Perform   other   duties   as   assigned .

Required Qualifications – CAN ’T CHANGE Bachelor’s degree in a rel ated field OR an equivalent combination of education and work experience.

Minimum 3 years’ in 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 (imaging, laboratory), and medications (class, dose, route).

Certified Clinical Data Manager (CCDM) or equivalent.

Preferred   Qualifications – CAN CHANGE Bachelor’s degree in business administration, data science , statistics or life sciences.

3 years’ e xperience in c linical operations or healthcare related field .

K nowledge   of   data   management   practices   from   CRF   design   to   database   development   and   study   closure .

Experience   with   using   El ec tronic Data Ca pture ( EDC )   databases and adva nced s kill level workin g in Excel .

Knowledge of documentation practices in-line with  Good Clinical Data Management Practices , and other FDA regulations   and   guidelines   is   required .

Ability to  leverage  and/or engage others  to accomplish  projects.

S olid   oral   and   written   communication   skills   and   analytical / problem- solving skills .

Must be able to effectively manage multiple projects and timelines .

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

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.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf