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 109,000 colleagues serve people in more than 160 countries.
For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it’s glucose monitoring systems, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks.
Our location in Sylmar, CA currently has an opportunity for a Clinical Data Systems Analyst II.
Working under general supervision, is responsible for various special projects related to the data systems aspects of the clinical studies conducted. These special projects will include implementing new, updated and/or enhanced systems that are responsible for data collection for clinical studies as well as providing assistance to multiple customers globally, externally and internally.. As a business analyst, participates in the collection of project requirements analyzing business needs. 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 proactive planning, organizing and performing work; monitors performance and effectively communicates status within area of responsibility. Assures that quality of services meets internal and external customer requirements.
WHAT YOU’LL DO
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Actively supports, leads and collaborates with other team members to complete projects. Performs as liaison between internal and external customers and the clinical data systems software engineers. Practices effective communication, active listening and team work.
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Proficient ability to analyze user requirements, procedures, and problems and to gather, organize, write and produce project requirements and specifications documentation that clearly states what is needed for the application; including leading meetings/discussion with direct manager regarding systems and/or processes, take meeting minutes and providing communication regarding the progress of project
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Proficient ability to understand and perform user acceptance testing from the creation of test scripts through execution; includes providing any related findings that are applicable throughout the testing phase
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Proficient contribute in writing technical documentation and manuals
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Proficient ability to communicate customer-requested changes to the developer regarding the system, as well as communicate any issues with development to the system directly to the external and/or internal customers
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Ability to discuss all assigned projects with general supervision and be able to answer any detailed question regarding the project impacts on other systems
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Proficient ability to communicates well with all levels of employees including peers, study teams and management to support studies and goals
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Proficient Support Line contact addressing requestor’s issues in a timely and efficient manner delegating to proper CDSA as needed
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Proficient understanding of clinical data collection tools with an emphasis on Oracle Clinical and Oracle Clinical’s Remote Data Capture (RDC) system
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Proficient experience with Software Development Lifecycle (SDLC)
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Follows and provides input to Departmental Standard Operating Procedures (SOPs), Departmental Work Instruction (DWIs), and guidelines
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Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
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Proficient knowledge and complies with Good Clinical Practices (GCP), US Food and Drug Administration (FDA) regulations, International Conference on Harmonization (ICH), ISO 14155, other regulatory requirements, applicable company policies, operating procures and processes
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Performs other related duties and responsibilities, on occasion, as assigned
EDUCATION AND EXPERIENCE YOU’LL BRING
Required
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Bachelor Degree in Computer Science, Health Sciences, related field or equivalent
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Minimum 3 years of experience working in a clinical research environment and/or healthcare industry experience
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Organizational skills and attention to detail
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Highly skilled with Microsoft office products including Word, Excel, and Access
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Proficient ability to work with database management systems
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Proficient knowledge of database terminology and technology
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Preferred knowledge of Relational Databases and demonstrated ability to generate queries using Query languages like Structured Query Language (SQL)
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Proficient knowledge and experience building/customizing Clinical Trial Management Software Applications
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Ability to work in a highly matrixed and geographically diverse business environment.
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Proficient ability to work within a team and as an individual contributor in a fast-paced, changing environment
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Strong oral and written communication skills
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Ability to meet deadlines and handle multiple assignments in a timely manner, and meet assigned deadlines.
WHAT WE OFFER At Abbott, you can have a good job that can grow into a great career. We offer:
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Training and career development, with onboarding programs for new employees and tuition assistance
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Financial security through competitive compensation, incentives and retirement plans
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Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
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Paid time off
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401(k) retirement savings with a generous company match
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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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Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.