Clinical Data Analyst

Job Description

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.

Structural Heart Business Mission: why we exist

Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease.
We aim to lead the markets we serve by requiring the solutions we offer customers provide an improved benefit/risk profile as compared to existing standards of care; a performance threshold that by definition, guides and ensures the productive output of our engineering, business development, and clinical research efforts result in outcomes that advance the standard of care.

MAIN PURPOSE OF ROLE

Working under general supervision, is responsible for all aspects of data management activities in support of assigned clinical studies. These activities help to ensure high quality data is achieved in support of analysis for regulatory submissions, safety monitoring and publications. Ensures that Good Clinical Practices (GCP), Good Clinical Data Management Practices (GCDMP) and established processes are followed. Identifies and routinely uses the most effective, cost efficient and best business practices to execute processes; continually evaluates their effectiveness and appropriateness. Exercises judgment in planning, organizing and performing work; monitors performance and reports status within area of responsibility. Ensures that quality of services meets internal and external customer requirements.

WHAT YOU’LL DO

Represents Data Management at Study Team Meetings
Reviews protocols and statistical analysis plans
Performs all data management activities for assigned studies, as appropriate
o Protocol and Statistical Analysis Plan (SAP) review and input
o Case Report Form (CRF) development and maintenance
o Edit Check specifications development and maintenance
o Data Management Plan development and maintenance
o Data Quality Checks and discrepancy management
o Analyzes data, identifies trends; prepares data tables for reports
o Database setup testing and Edit Check programming testing
o External data handling
o Device reconciliation and tracking for investigational product
o Participate in Post Market Surveillance reporting as appropriate
o Additional study specific activities
Develops the study specific Data Management Plans (DMPs)
Ensures data integrity and accuracy of the clinical data through the specification of data quality checks and development of SQL cleaning queries
Ensures that all data management activities for assigned studies are completed on time and with high quality or escalates as appropriate
Communicates well with peers, study teams and management as appropriate to support studies and goals
Participates in efforts to improve Data Management processes, as needed/assigned
Identifies and routinely uses the most effective, cost efficient and best business practices to execute processes and continually evaluates their effectiveness and appropriateness
Will also participate in process improvements and standardizations
Applies best practices and established standards
Serves as a liaison between the study team and clinical data operations
Is a Subject Matter Expert (SME) in one or more areas within Data Management

EDUCATION AND EXPERIENCE YOU’LL BRING

Education
Bachelors Degree (± 16 years) Computer Science, related field or an equivalent combination of education and work experience

Experience/Background
Experience
Minimum 4 years In a clinical research environment, experience to include a thorough understanding of data management processes.
General knowledge of database terminology and technology, knowledge of basic Structured Query Language (SQL) and demonstrated ability to generate queries. Demonstrated familiarity with MS Office, especially Word and Excel. Demonstrated oral and written interpersonal, communication, analytical, presentation, and organizational skills; the ability to meet deadlines/work independently. Must be adept at handling multiple assignments in a timely manner and meeting assigned deadlines.
Must have the demonstrated ability to understand and comply with applicable U. S. Food & Drug Administration (FDA) regulations and Company operating procedures, processes, policies, and tasks.
Preferred-Oracle Clinical, clinical data management systems along with familiarity with EDC and paper-based studies. Understanding of human physiology and cardiac pacing.
A Certified Clinical Data Manager (CCDM) is preferred.

WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:

• Training and career development, with onboarding programs for new employees and tuition assistance
• Financial security through competitive compensation, incentives and retirement plans

• Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
• Paid time off
• 401(k) retirement savings with a generous company match
• The stability of a company with a record of strong financial performance and history of being actively involved in local communities

Learn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.

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