AbbVie
Systems Design Analyst I (Hybrid)
AbbVie, Irvine, California, United States,
Job Description
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.
Description:
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
Based on supported domain, builds specifications for data acquisition from third-party systems.
Acts as general DS technology point of contact and works closely with data and statistical colleagues to troubleshoot data or process flow interruptions, as well as potential errors.
Acts as the clinical data systems SME during regulatory inspections and internal quality audits.
.
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.
Description:
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
Based on supported domain, builds specifications for data acquisition from third-party systems.
Acts as general DS technology point of contact and works closely with data and statistical colleagues to troubleshoot data or process flow interruptions, as well as potential errors.
Acts as the clinical data systems SME during regulatory inspections and internal quality audits.
.