System Design Analyst II-Clinical Systems- HYBRID

AbbVie; Florham Park (NJ); On-site; USD 150,000 - 190,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k) retirement plan

Short-term incentive programs

Job summary

AbbVie Data Science leads the delivery of data strategy for clinical trials, focusing on design standards, data flow, and system integrations. The team coordinates across regulatory, data management, and IT to ensure compliant, scalable solutions.

The role requires deep knowledge of CDASH/SDTM, 5+ years in EDC, and the ability to mentor teams while driving process improvements in a fast-paced, regulated environment.

Qualifications

• Bachelor’s degree in business, MIS, computer science, life sciences or equivalent
• Masters preferred
• 5+ years of hands-on technical Study build in EDC
• Experience with Medidata RAVE is required
• Veeva EDC technical study build experience is a plus
• In-depth knowledge of clinical trial processes
• CDASH and SDTM knowledge
• Ability to influence without direct authority
• Strong communication and analytical skills

Responsibilities

• Actively participates in developing common data standards and ensures designs comply with standards and protocol requirements
• Establishes and maintains methodology to design and develop clinical trial systems, benchmarking against industry standards
• Ensures TA- and program-level consistency in design team outputs
• Accountable for on-time design and delivery of new clinical systems and integrations
• Interacts with CDO and cross-functional team members to align objectives
• Ensures adherence to GCPs, ICH guidelines, AbbVie SOPs, and regulatory standards
• Coaches and mentors team members and leads innovation and process improvement

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. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Company Description

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. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

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 Clinical Data Strategy Organization.

• Actively participates in the development of common data standards and ensures 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 clinical trial systems, benchmarking against industry standards. Ensures that systems are specified to optimize 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 as any required changes to clinical systems (e.g., EDC, IRT, ePRO). 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 CDO 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 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 CDO 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 hands-on technical Study build in EDC. Experience with technical study build in Medidata RAVE is required. Veeva EDC technical study build experience is a plus.
• In-depth knowledge of clinical trial processes.
• In-depth knowledge of CDASH (Required) 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.

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 we may ultimately pay more or less than the posted range. This range 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 short-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

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

https://www.abbvie.com/join-us/reasonable-accommodations.html