Manager, Clinical Data Review

Manager, Clinical Data Review

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.

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.

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.

Bachelor's degree in a science-related field or an equivalent combination of education and experience. Minimum 8 years' progressively more responsible experience in the pharmaceutical, bio-technology or medical device industry; must be able to apply the fundamental concepts and practices to conduct needs assessment, research and develop information for market development purposes. Advanced…