Associate Clinical Data Manager

About this role

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

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