ABBOTT LABORATORIES Manager, Clinical Data Systems Salary in the United States

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 103,000 colleagues serve people in more than 160 countries.

Responsible for managing Clinical Data Systems (Applications/Reports/Dashboards/Alerts) ensuring that processes and people are in place to achieve required development effort with high level of accuracy and data integrity for the Global Clinical Operations team at Abbott Medical Devices.  Responsible for development of enhancements and streamlining business processes related to the clinical data systems.  Exercises technical judgment in planning, organizing, and directing staff to support study database development, perform system configuration/validation and develop custom reports/applications using .Net, Angular, Xamaran, PL/SQL, SSRS, PowerBI and other development tools.  Exercises judgment in planning, organizing and performing work; monitors performance and reports status within area of responsibility. 

Job Duties:

• Manages and supervises clinical data systems personnel in the implementation of systems development processes to ensure the integrity of data entered into the clinical data systems throughout the duration of a study. 
• Architect and Lead the full life-cycle development (SDLC) of mission critical platforms/applications for the Global Clinical Operations organization at Abbott.
• Mentoring and growing engineers, performs code-reviews, provides hands on programming, and management of the development of applications utilizing the latest technologies including but not limited to .Net, Angular, MVC, PL/SQL, CI/CD, PowerBI and Azure Cloud. 
• Oversees Abbott activities related to the development, testing, and release of new studies created in the clinical relational database management system (Oracle Clinical) to ensure consistency and efficiency in the utilization of the system functionality.
• Determines appropriate business requirements to define and refine specifications for the development of reports and applications to aid Field and In-house Clinical Research personnel in managing clinical studies. 
• Leads Clinical Data Systems programs; may lead project teams or task force to address strategic departmental projects, assignments and/or initiatives.  
• Facilitates efforts geared toward clinical data systems administration, architecture and security.
• Develops, revises, and enforces the Clinical Data Operations Standard Operating Procedures and Work Instructions as required.
• Remains current on developments in field(s) of expertise, regulatory requirements, and a comprehensive knowledge of the company's products, markets, as well as industry trends; updates and creates programs/processes to ensure that staff remains technically current.  Maintains knowledge of current and pending regulations through reviewing key literature, trade journals, professional associations, and by attending conferences.
• Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Maintains a safe and professional work environment.
• 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.

Qualifications:

General Qualifications

• Bachelor’s degree in Computer Science, Engineering, a related field, or equivalent. 
• Minimum of seven plus years of progressively more responsible experience in: a medical device/pharmaceutical or biotech company; the initiation and management of software development projects including collecting specifications and documenting business requirements; “hands-on” experience with the extensive software development, testing, and verification. 
• Demonstrated understanding of relational database concepts.  Strong system implementation skills and user training experience. 
• Requires leadership skills/experience sufficient to assume the responsibilities of this management position, including the ability to map task interdependencies, multi-task, prioritize such tasks, meet deadlines, and develop, monitor and live within budgets as well as the demonstrated ability to forecast major milestones. 
• Must be skilled at delegation, follow-up, and team building.  Requires the ability to change the thinking of, or gain acceptance of, others in sensitive situations. 
• Documented record of delivering information that adds value to management’s decision making process.  Demonstrated ability to understand and comply with applicable U. S. Food & Drug Administration (FDA), Technischer Uberwachungsverein (TÜV), Good Manufacturing Practices (GMP), and Good Clinical Practices (GCP) regulations as well as Company operating procedures, processes, policies, and tasks. 

Desired:              

• An advanced credential in a relevant discipline/concentration.  Professional certification or designation.  Academic or in-house courses in leadership, training, relational data base programs, Continuous Improvement (CI), cycle time improvement, plus cardiac pacing, are preferred.  Knowledge of cardiac pacing is a decided advantage, as is knowledge of Oracle Clinical, relational data base is also desired.
• 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 15%, including internationally.
• Ability to maintain regular and predictable attendance.