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Systems Design Analyst I

Employer
AbbVie
Location
Irvine, California
Start date
Sep 9, 2021

Job Details

About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

AbbVie Data Science is the best-in-class team within its cross-industry peer group and is responsible for bringing people, process, and technology together to generate business value from clinical trials data. Our operational model is exemplified through execution and innovation.  This role is key to ensuring successful delivery against the program- and study-level accountabilities assigned to Data and Statistical Sciences.   

Responsibilities:

•Ensures that the requirements of each study protocol are reflected in systems designs and that common data standards are used

•Ensures that systems are specified to optimize on functionality, end user experience, and data flow

•Accountable for the on-time design and delivery of new clinical systems, integrations between systems, as well any required changes to clinical systems (e.g., EDC, IRT,).  Utilizes project management tools to track study progress and plan work.  Anticipates and identifies issues that could affect timelines or quality and develops options and solutions

•Ensures that TA- and program-level consistency is achieved

•Interacts with and influences DSS and cross-functional team members to achieve program and study objectives.  Ensures that assigned work product is synchronized with upstream and downstream dependencies

•Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and to functional quality standards.  Stays abreast of new and/or evolving local regulations, guidelines and policies related to clinical development

•Responsible for coaching and mentoring Data Science Associates

•Participates in DSS and cross-functional innovation and process improvement initiatives


Qualifications

Qualifications:

•Bachelor’s degree in business, management information systems, computer science, life sciences or equivalent.  Masters preferred

•Must have 3+ years of clinical technology experience (e.g., EDC, IRT, ePRO) or 5+ years of experience in a similar technical role or in a clinical development role.  Experience with common industry design and development tools preferred

•Demonstrated understanding of clinical trial process

•Knowledge of CDASH and SDTM

•Demonstrated ability to influence of others without direct authority

•Demonstrated effective communication skills

•Demonstrated effective analytical skills


Significant Work Activities
N/A
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.

Company

AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, and YouTube.

Stock Symbol: ABBV

Stock Exchange: NYSE

Company info
Website
Phone
1-800-255-5162
Location
1 North Waukegan Road
North Chicago
Illinois
60064
US

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