Systems Design Analyst II

AbbVie; Irvine (CA); On-site; USD 100,000 - 130,000; Full time

Benefits offered by this job

Comprehensive benefits package

Paid time off

401(k) participation

Job summary

AbbVie is seeking a key individual to lead the design and development of clinical trial systems in Irvine, California. This role focuses on ensuring adherence to standards while mentoring team members and driving innovative solutions. Candidates should possess 5+ years of experience in clinical technologies, strong project management skills, and the ability to influence cross-functional teams.

The position offers a comprehensive benefits package and opportunities for contribution to the organization’s success.

Qualifications

• 5+ years of clinical technology experience or 7+ years in a similar role.
• In-depth knowledge of clinical trial processes and CDASH/SDTM.
• Demonstrated ability to coach and mentor team members.

Responsibilities

• Participate in the development of common data standards.
• Ensure methodology aligns with industry standards.
• Accountable for the timely design and delivery of clinical systems.

Skills

Clinical technology experience

Project management

Influencing and mentoring

Education

Bachelor’s degree in relevant field

Master’s degree preferred

Tools

EDC

IRT

ePRO

Job description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions 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 including immunology, oncology and neuroscience, and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com.

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Job Description

AbbVie Data Science is a 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 participate in the development of common data standards and ensure systems designs comply with the standards and protocol requirements, ensuring that the design team utilizes standards.
• Establish and maintain the methodology used by the team to design and develop clinical trial systems, benchmarking against industry standards, ensuring systems are specified to optimize functionality, end‑user experience, and data flow, and ensuring the design team meets these expectations.
• Ensure that therapeutic area 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, and any required changes to clinical systems (e.g., EDC, IRT, ePRO). Utilize project management tools to track study progress and plan work, anticipate and identify issues that could affect timelines or quality, and develop options and solutions.
• Interact with and influence DSS and cross‑functional team members to achieve program and study objectives, ensuring that assigned work product is synchronized with upstream and downstream dependencies.
• Ensure adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and functional quality standards, while staying abreast of new and evolving local regulations, guidelines, and policies related to clinical development.
• Coach and mentor team members, contributing to their skill development.
• Lead DSS and cross‑functional innovation and process improvement initiatives.

Qualifications

• Bachelor’s degree in business, management information systems, computer science, life sciences or equivalent; Master’s preferred.
• Must have 5+ years of clinical technology experience (e.g., EDC, IRT, ePRO) or 7+ years in a similar technical or clinical development role, with experience in common industry design and development tools.
• In‑depth knowledge of clinical trial processes and 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, coach and mentor in a matrixed environment, and communicate effectively and analytically.

Additional Information

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our long‑term incentive programs.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only – to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html