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Systems Design Analyst II

Employer
AbbVie
Location
Branchburg Township, New Jersey
Start date
Nov 17, 2023

Job Details

Purpose:

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:

•Actively participates in the development of common data standards and ensures EDC systems designs comply with the standards, as well as with associated protocol requirements.  Ensures that the design team utilizes standards

•Establishes and maintains methodology used by the team to design and develop EDC systems, benchmarking against industry standards.  Ensures that systems are specified to optimize on functionality, end user experience, and data flow. Ensures that the design team meets these expectations

•Ensures that TA- and program-level consistency is achieved by the design team

•Accountable for the on-time design and delivery of new clinical systems, integrations between systems, as well any required changes to EDC systems.  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

•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 members of the team, as well as contributes to their skill development

•Leads DSS and cross-functional innovation and process improvement initiatives


Qualifications:

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

•Must have 5+ years of EDC clinical technology experience. Experience with Veeva CDMS Studio preferred.

•In-depth knowledge of clinical trial process.  In-depth knowledge of CDASH and SDTM.

•Demonstrated performance as a key contributor to initiatives and advancement of the organization.

•Demonstrated ability to influence others without direct authority.  Demonstrated ability to successfully coach / mentor in a matrixed environment.  Demonstrated effective communication skills and analytical skills.

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a protected veteran, or any other legally protected group status.


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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