The Opportunity

We are looking for our nextManager, Clinical DataReviewto 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, providingdatasetsand performing data cleaning for analysis. Additionally,willidentifyand 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,organizingand performing work;monitorperformance 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) ofexpertiseto ensure that clinical trial protocol elements are appropriately captured on CRFs and databases for analysis; responsible for ensuring database integrity.

WhatYoullWork On

Responsible for hiring andretaininga 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.Modelsoptimumleadership competencies to inspire an energized,empoweredand accountable work force, ethical behavior, favorable community image, and actualization of theAbbottGuiding Principles and values.

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

Oversees the development of CRFs, edit check specifications, andadditionaldata collection requirementsrequiredfor 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;identifiestrends, risks, and opportunities for improvement andimplementscorrective actions as needed.Remains current on developments in field(s) ofexpertise, regulatory requirements, and industry trends and trains staffregardingchanging regulations that affect clinical studies. Maintains knowledge of current and pending regulations through literature, trade journals, professional associations, and by attending conferences.

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

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

Complies withU.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Required Qualifications

Bachelor's degree in a science-related field or an equivalent combination of education and experience

Minimum 8 yearsprogressively more responsible experience in the pharmaceutical,bio-technologyor 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 computer skills in graphics, word-processing, databases, authoring programs, etc.

Advanced personal computer skills (experience with Microsoft Office or equivalent required) in graphics, word-processing, databases, authoring programs, etc

Experience working in a broader enterprise/cross division business unit model preferred. Ability to work in a highly matrixed and geographically diverse business environment. Strong leadershipskills,includingthe ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results. Ability to work effectively within a team in a fast-paced changing environment. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multi-tasks, prioritizes and meets deadlines in timely manner. Strong organizational, planning, and follow-up skills and ability to hold others accountable.

Ability to travel approximately 20%, including internationally.

Preferred Qualifications

Experience working in a broader enterprise/cross division business unit model

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