Manager, Clinical Data Review

Required Qualifications

• 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 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 leadership skills, including the 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.

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 and collaboration with all levels of employees, customers, contractors, and vendors.