Manager, Clinical Data Review

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   fingersticks .  

The Opportunity   

We are looking for our next   Manager, Clinical Data   Review   to lead our team on-site out of our Maple Grove, MN .    As a manager, the individual has primary management responsibility directly or through subordinates for all data related to clinical studies. This new team member will have accountability for all data entry activities, Case Report Form (CRF) design, edit check specifications, and other requirements of the Clinical databases, providing   datasets   and performing data cleaning for analysis. Additionally,   will   identify   and routinely use the most effective, cost efficient and best business practice to execute processes; continually evaluate their effectiveness and appropriateness. The Manager, Clinical Data Review will exercise judgment in planning,   organizing   and performing work;   monitor   performance and report statuses to executive management as well as assures that quality of services meets internal and external customer requirements. The individual will remain current on developments in field(s) of   expertise   to ensure that clinical trial protocol elements are appropriately captured on CRFs and databases for analysis; responsible for ensuring database integrity.  

What   You’ll   Work On   

Responsible for hiring and   retaining   a diverse , highly qualified data management staff and for providing career coaching, growth, and personal development. Accountable for staff development: critiques,   instructs , mentors,   evaluates , and coaches. Ensures staff is appropriately trained in processes and procedures; ensures established processes and procedures are being followed and documented. Accountable for the performance of subordinates and work output of managed subcontractors. Maintains a safe work environment and a strong customer focus.   Models   optimum   leadership competencies to inspire an energized,   empowered   and accountable work force, ethical behavior, favorable community image, and actualization of the   Abbott   Guiding Principles and values.  

Manages data entry, data cleaning, data deliverables, and other data management activities.  

Oversees the development of CRFs, edit check specifications, and   additional   data collection requirements   required   for tracking and analysis.  

Manages the implementation and execution of Risk-Based Quality Management (RBQM) activities, including risk assessments, risk mitigation plans, data review strategies, centralized monitoring activities, and Key Risk Indicator (KRI) oversight  

Manages processes to ensure data integrity via appropriate data management processes (e.g., protocol compliance reporting, querying for missing or discrepant data, evaluating data outliers, performing data quality checks, etc.).  

Monitors operational performance and quality indicators;   identifies   trends, risks, and opportunities for improvement and   implements   corrective actions as needed.   Remains current on developments in field(s) of   expertise , regulatory requirements, and industry trends and trains staff   regarding   changing regulations that affect clinical studies. Maintains knowledge of current and pending regulations through literature, trade journals, professional associations, and by attending conferences.  

Hires and   retains   a diverse , highly qualified staff and provides ongoing performance feedback. Sets goals which align to department plans and   manages   the execution of goals through coaching and mentoring. Maintains a safe and professional work environment.  

Support all Company initiatives as   identified   by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.  

Complies with   U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications

Similar jobs

• Senior Manager, Clinical Data Management — Corcepttherapeutics · Redwood City, California, United States
• Manager/Senior Manager, Clinical Data Management — Beamtherapeutics · Cambridge, MA
• Sr. Clinical Data Manager — Fortrea · Remote
• Associate Director, Clinical Data Management — Corcepttherapeutics · Redwood City, California, United States
• Manager, Clinical Trial Management — Pfm · Remote
• Manager, Clinical Trial Management — Precisionmedicinegroup · Remote
• Senior Clinical Research Manager — BeiGene · Remote
• Clinical Data Manager II/Senior Clinical Data Manager — Precisionmedicinegroup · Remote